Cleared Traditional

K843750 - APPARATUS, SUCTION, WARD USE, PORTAB-

K843750 is an FDA 510(k) clearance for APPARATUS, manufactured by H.C.H. Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K843750 · H.C.H. Products, Inc. · General & Plastic Surgery device
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Oct 1984
Decision
16d
Days
Class 2
Risk

K843750 is an FDA 510(k) clearance for the APPARATUS, SUCTION, WARD USE, PORTAB-. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by H.C.H. Products, Inc. (Blasdell, US). The FDA issued a Cleared decision on October 11, 1984 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all H.C.H. Products, Inc. devices

FDA 510(k) Submission Details - K843750

510(k) Number K843750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1984
Decision Date October 11, 1984
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 111
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K843750.
PORTASPIR II
K851560 · Roseburg SA · Dec 1985
STORZ ASPIRATION MACHINE SAM 5000
K843644 · Storz Instrument Co. · Nov 1984
JACOBS HIGH VACUUM SUCTION UNIT 05-2570
K843693 · J. Sklar Mfg. Co., Inc. · Oct 1984
BRONCHOSCOPE SUCTION UNIT
K841399 · Keymed, Inc. · Jul 1984
EMERGENCY ASPIRATOR
K833785 · Vitalograph , Ltd. · Dec 1983
PSI SURGICAL ASPIRATOR
K832100 · Advanced Biosearch Assn. · Oct 1983