Cleared Traditional

K926140 - VACUUM POWER BODY FLUID SUCTION APPARATUS
(FDA 510(k) Clearance)

Jul 1993
Decision
232d
Days
Class 2
Risk

K926140 is an FDA 510(k) clearance for the VACUUM POWER BODY FLUID SUCTION APPARATUS. This device is classified as a Regulator, Vacuum (Class II - Special Controls, product code KDP).

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on July 27, 1993, 232 days after receiving the submission on December 7, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K926140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1992
Decision Date July 27, 1993
Days to Decision 232 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KDP — Regulator, Vacuum
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6740

Similar Devices — KDP Regulator, Vacuum

All 20
BOEHRINGER MRI SUCTION REGULATORY
K013976 · Boehringer Laboratories · Jan 2002
PM3300 INTERMITTENT VACUUM
K944479 · Precision Medical, Inc. · Dec 1994
MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )
K942747 · Engineered Orthopedic Technologies, Inc. · Jul 1994
BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED
K933232 · Boehringer Laboratories · Mar 1994
PM3000 & PM3100 VACUUM REGULATOR
K922817 · Precision Medical, Inc. · Mar 1993
OHMEDA CONTINUOUS SUCTION REGULATOR
K883229 · Ohmeda Medical · Oct 1988