FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

Regulation Number

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 9 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

RAND NASAL PACKING

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-10-18

(23 days)

Product Code

Regulation Number

Type

Panel

Ear Nose & Throat

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

SPIRIT RIDGE SILICONE CARVING BLOCK

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-05-22

(65 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

DURALASTIC SHEETING II

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-05-16

(59 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-05-16

(148 days)

Product Code

Regulation Number

N/A

Type

Panel

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as requested in the prompt. The document describes toxicology tests, eye irritation tests, and cytotoxicity tests for a contact lens material, along with design specifications and a comparison to a predicate device. However, it does not provide details like a table of acceptance criteria vs. reported performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, details of MRMC or standalone studies, or ground truth establishment for training and test sets.

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

THE MAGNUM CHIN IMPLANT

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-04-19

(32 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-04-19

(29 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

MEDIAL MALAR IMPLANT

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-04-19

(32 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-04-19

(32 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS

Manufacturer

RAND SCIENTIFIC CORP.

Date Cleared

1996-03-28

(127 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

Page 1 of 1