BYX · Tubing, Pressure And Accessories
Anesthesiology · 21 CFR 868.5860 · Class 1
Overview
| Product Code | BYX |
|---|---|
| Device Name | Tubing, Pressure And Accessories |
| Regulation | 21 CFR 868.5860 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.
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 62)
Showing 20 most recent of 62 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011134 | OXYGEN SUPPLY TUBING, MODEL 1115 | Hudson Respiratory Care, Inc. | Jun 13, 2001 | SESE |
| K955656 | NORTH STATE PLASTICS AEROSOL TEE | North State Plastics, Inc. | Mar 6, 1996 | SESE |
| K943110 | GAS SAMPLING INTERFACES | Coast Medical, Inc. | Aug 19, 1994 | SESE |
| K935835 | BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES | Busse Hospital Disposables, Inc. | Jan 12, 1994 | SESE |
| K931043 | MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS | Medical Fittings, Inc. | Jun 1, 1993 | SESE |
| K931033 | MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS | Medical Fittings, Inc. | Jun 1, 1993 | SESE |
| K913422 | OXYGEN TUBING, 81503 | Specialty Packaging Producs, Inc. | Jan 30, 1992 | SESE |
| K914980 | HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES | Medical Fittings, Inc. | Jan 21, 1992 | SESE |
| K912763 | OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS) | Medical Fittings, Inc. | Oct 15, 1991 | SESE |
| K905091 | VARIOUS MALE QUICK CONNECTS. | Medical Fittings, Inc. | Mar 4, 1991 | SESE |
| K905094 | SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN | Medical Fittings, Inc. | Nov 20, 1990 | SESE |
| K904757 | OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS | Medical Fittings, Inc. | Oct 31, 1990 | SESE |
| K904702 | MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS | Medical Fittings, Inc. | Oct 31, 1990 | SESE |
| K904701 | MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN | Medical Fittings, Inc. | Oct 31, 1990 | SESE |
| K904337 | OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN. | Medical Fittings, Inc. | Oct 4, 1990 | SESE |
| K901983 | OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP. | Medical Fittings, Inc. | Aug 14, 1990 | SESE |
| K901961 | OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER | Medical Fittings, Inc. | Aug 14, 1990 | SESE |
| K863912 | THE MMG 5 IN 1 CONNECTOR | Medical Marketing Group | Oct 27, 1986 | SESE |
| K860877 | FLEXTUBE, CONNECTING TUBING | Dhd Medical Products Div. Diemolding Corp. | Mar 20, 1986 | SESE |
| K854239 | OXYCOIL | Chad Therapeutics, Inc. | Nov 14, 1985 | SESE |
Top Applicants
- Medical Fittings, Inc. — 12 clearances
- Airlife, Inc. — 7 clearances
- Timeter Instrument Corp. — 5 clearances
- Mem Medical, Inc. — 3 clearances
- Todd Industries, Inc. — 3 clearances
