KDQ · Bottle, Collection, Vacuum
General Hospital · 21 CFR 880.6740 · Class 2
Overview
| Product Code | KDQ |
|---|---|
| Device Name | Bottle, Collection, Vacuum |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081718 | EXPRESS CHEST DRAIN | Atrium Medical Corp. | Jul 25, 2008 | SESE |
| K062302 | MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM | Millicore AB | Oct 6, 2006 | SESE |
| K043582 | OCEAN CHEST DRAIN | Atrium Medical Corp. | Jan 21, 2005 | SESE |
| K984496 | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN | Atrium Medical Corp. | May 5, 1999 | SESE |
| K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR | Deknatel, Inc. | Aug 28, 1996 | SESE |
| K961287 | ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM | Rocket Medical Plc | Jul 26, 1996 | SESE |
| K962168 | MUCUS SPECIMEN TRAP | Sage Products, Inc. | Jul 22, 1996 | SESE |
| K950677 | ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN | Atrium Medical Corp. | Apr 13, 1995 | SESE |
| K941818 | PM9000 VAC TRAP | Precision Medical, Inc. | Dec 12, 1994 | SESE |
| K932327 | THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM | Davol, Inc. | Jul 13, 1993 | SESE |
| K912704 | ATRIUM 2000 CHEST DRAIN | Atrium Medical Corp. | Aug 26, 1991 | SESE |
| K905768 | PLEUR-EVAC CHEST DRAINAGE SYSTEMS | Deknatel, Inc. | Feb 11, 1991 | SESE |
| K897125 | ATRIUM 2000, CHEST DRAIN | Atrium Medical Corp. | Mar 30, 1990 | SESE |
| K896697 | PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI | Deknatel, Inc. | Feb 8, 1990 | SESE |
| K896127 | THORA-KLEX CHEST DRAINAGE UNIT | Davol, Inc. | Jan 24, 1990 | SESE |
| K892915 | PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION | Deknatel, Inc. | Jun 21, 1989 | SESE |
| K882468 | ELIMINATOR AIR FILTER | Apex Medical, Inc. | Aug 29, 1988 | SESE |
| K882223 | PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST | Deknatel, Inc. | Aug 16, 1988 | SESE |
| K881149 | MUCUS TRAP OR SUCTION TRAP | Ferguson Medical | Jun 14, 1988 | SESE |
| K863561 | URESIL THORACIC VENT | Uresil Corp. | Sep 23, 1986 | SESE |
Top Applicants
- Atrium Medical Corp. — 8 clearances
- Deknatel, Inc. — 5 clearances
- Abco Dealers, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Boehringer Laboratories — 2 clearances
