CAI · Circuit, Breathing (W Connector, Adaptor, Y Piece)
Anesthesiology · 21 CFR 868.5240 · Class 1
Overview
| Product Code | CAI |
|---|---|
| Device Name | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Regulation | 21 CFR 868.5240 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (20 of 184)
Showing 20 most recent of 184 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954480 | CONDENSATE COLLECTION KIT | Nova-Ventrx | Dec 29, 1995 | SESE |
| K953788 | UNICOR, INC. GAS SAMPLING LINES & CONNECTORS | Unicor, Inc. | Sep 19, 1995 | SESE |
| K953787 | UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT | Unicor, Inc. | Sep 19, 1995 | SESE |
| K952020 | PRIMA PEDIATRIC ANESTHESIA CIRCUITS | Prima, Inc. | May 22, 1995 | SESE |
| K952019 | PRIMA ADULT GAS SAMPLING CIRCUITS | Prima, Inc. | May 22, 1995 | SESE |
| K952018 | PRIMA COAXIAL CIRCUITS | Prima, Inc. | May 22, 1995 | SESE |
| K952017 | PRIMA MAPLESON D CIRCUIT | Prima, Inc. | May 22, 1995 | SESE |
| K952016 | PRIMA PEDIATRIC GAS SAMPLING CIRCUITS | Prima, Inc. | May 22, 1995 | SESE |
| K952014 | PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | Prima, Inc. | May 22, 1995 | SESE |
| K952009 | PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Prima, Inc. | May 19, 1995 | SESE |
| K945565 | SPIRO-FLEX | Inhalation Plastics | Jan 13, 1995 | SESE |
| K932288 | NEONATAL BREATHING CIRCUIT MODIFICATION | Simplex Medical Systems, Inc. | Dec 30, 1994 | SESE |
| K945984 | MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS | Meridian Medical Systems, Inc. | Dec 27, 1994 | SESE |
| K944533 | PRIMA, INC. ADULT ANESTHESIA CIRCUIT | Prima, Inc. | Nov 29, 1994 | SESE |
| K945314 | CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING | Cleveland Tubing, Inc. | Nov 18, 1994 | SESE |
| K944429 | PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING | Precision Thermoplastic Components, Inc. | Nov 18, 1994 | SESE |
| K940890 | CORRUGATED TUBING | Cleveland Tubing, Inc. | Nov 10, 1994 | SESE |
| K940889 | CONNECTORS AND AIRWAY EXTENSIONS | Cleveland Tubing, Inc. | Nov 10, 1994 | SESE |
| K944295 | KARL STORZ LARYNGOSCOPE ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Oct 4, 1994 | SESE |
| K942136 | M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Mag, Inc. | Jun 22, 1994 | SESE |
Top Applicants
- Mag, Inc. — 15 clearances
- Sigma Medical, Inc. — 13 clearances
- Life Shield Healthcare Products, Inc. — 10 clearances
- Precision Med Products, Ltd. — 10 clearances
- Med-Plastics Intl., Inc. — 9 clearances
