Cleared Traditional

K844200 - K.M. PRODUCTS ASPIRATOR

K844200 is an FDA 510(k) clearance for K.M. PRODUCTS ASPIRATOR, manufactured by Km Products. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K844200 · Km Products · General & Plastic Surgery device
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Jan 1985
Decision
87d
Days
Class 2
Risk

K844200 is an FDA 510(k) clearance for the K.M. PRODUCTS ASPIRATOR. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Km Products (Tucson, US). The FDA issued a Cleared decision on January 25, 1985 after a review of 87 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 Km Products devices

FDA 510(k) Submission Details - K844200

510(k) Number K844200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1984
Decision Date January 25, 1985
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 110
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K844200.
BUNN MODEL 530 ASPIRATOR
K870094 · The John Bunn Co. · Mar 1987
HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)
K862569 · Jedmed Instrument Co. · Aug 1986
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