Cleared Traditional

K884103 - REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES

K884103 is an FDA 510(k) clearance for REMOTE VACUUM BOOSTER SYSTEM, manufactured by Boehringer Laboratories. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K884103 · Boehringer Laboratories · General Hospital
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Mar 1989
Decision
155d
Days
Class 2
Risk

K884103 is an FDA 510(k) clearance for the REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 3, 1989 after a review of 155 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Laboratories devices

FDA 510(k) Submission Details - K884103

510(k) Number K884103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1988
Decision Date March 03, 1989
Days to Decision 155 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCX Device Classification - Class 2, Special Controls

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 57
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K884103.
PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN
K890431 · Deknatel, Inc. · Apr 1989
RECEPTAL SAF-GARD(TM) SYSTEM
K885208 · Abbott Laboratories · Mar 1989
VAC-RITE
K885334 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1989
PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE
K881252 · Deknatel, Inc. · Jun 1988
EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000
K873489 · J. H. Emerson Co. · Dec 1987
OHMEDA POSI-PULSE SUCTION UNIT
K861261 · Ohmeda Medical · May 1986