Cleared Traditional

K874505 - CONTAIN(TM)

K874505 is an FDA 510(k) clearance for CONTAIN(TM), manufactured by Arbor Technologies, Inc.. The device is a Class 2 General Hospital device with product code GCX cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K874505 · Arbor Technologies, Inc. · General Hospital
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May 1988
Decision
200d
Days
Class 2
Risk

K874505 is an FDA 510(k) clearance for the CONTAIN(TM). Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on May 20, 1988 after a review of 200 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 Arbor Technologies, Inc. devices

FDA 510(k) Submission Details - K874505

510(k) Number K874505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date May 20, 1988
Days to Decision 200 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 129d · This submission: 200d
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 58
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K874505.
VAC-RITE
K885334 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1989
REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES
K884103 · Boehringer Laboratories · 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
BOEHRINGER LABORATORIES SUCTION INTERMITTOR
K853095 · Boehringer Laboratories · Aug 1985