KDP · Regulator, Vacuum
General Hospital · 21 CFR 880.6740 · Class 2
Overview
| Product Code | KDP |
|---|---|
| Device Name | Regulator, 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 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013976 | BOEHRINGER MRI SUCTION REGULATORY | Boehringer Laboratories | Jan 8, 2002 | SESE |
| K944479 | PM3300 INTERMITTENT VACUUM | Precision Medical, Inc. | Dec 22, 1994 | SESE |
| K942747 | MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) | Engineered Orthopedic Technologies, Inc. | Jul 21, 1994 | SESE |
| K933232 | BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED | Boehringer Laboratories | Mar 28, 1994 | SESE |
| K926140 | VACUUM POWER BODY FLUID SUCTION APPARATUS | Hill-Rom, Inc. | Jul 27, 1993 | SESE |
| K922817 | PM3000 & PM3100 VACUUM REGULATOR | Precision Medical, Inc. | Mar 4, 1993 | SESE |
| K883229 | OHMEDA CONTINUOUS SUCTION REGULATOR | Ohmeda Medical | Oct 19, 1988 | SESE |
| K875074 | VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 | Timeter Instrument Corp. | Feb 22, 1988 | SESE |
| K853155 | BOEHRINGER LAB SUCTION INTERRUPTER | Boehringer Laboratories | Oct 16, 1985 | SESE |
| K850200 | SUCTION REGULATOR 7700 SERIES | Boehringer Laboratories | Mar 4, 1985 | SESE |
| K843591 | INTERCEPT | Vital Signs, Inc. | Oct 19, 1984 | SESE |
| K834224 | VACUUM REGULATOR 0-2000 MMHG VR-1000 | Trimeter Instrument Corp. | Feb 27, 1984 | SESE |
| K831505 | THORACIC GAUGE #TG-60 -VACUUM REGULATOR | Sorensen Research | Jul 12, 1983 | SESE |
| K830343 | CONTAINER W/PRIMING SOLUTION | American Hospital Supply Corp. | Mar 17, 1983 | SESE |
| K821314 | FEVER METER | Steridyne Corp. | May 28, 1982 | SESE |
| K820706 | WATERLESS SEAL & VACUUM REGULATOR | Sorensen Research | Apr 9, 1982 | SESE |
| K820077 | EMERSON THORACIC SUCTION REG. #55-JP | J. H. Emerson Co. | Jan 28, 1982 | SESE |
| K801169 | OHIO FREE FLOW VACUUM REGULATOR | Ohio Medical Products | Jul 28, 1980 | SESE |
| K770944 | INSTATEMP | H.I. Silverman, D.Sc. | Jul 27, 1977 | SESE |
| K760317 | REGULATORS, HIGH SUCTION | Harris-Lake, Inc. | Aug 4, 1976 | SESE |
Top Applicants
- Boehringer Laboratories — 4 clearances
- Harris-Lake, Inc. — 2 clearances
- Precision Medical, Inc. — 2 clearances
- Sorensen Research — 2 clearances
- American Hospital Supply Corp. — 1 clearance
