Cleared Traditional

K850946 - SURGICAL ASPIRATOR

K850946 is an FDA 510(k) clearance for SURGICAL ASPIRATOR, manufactured by Medicalex. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K850946 · Medicalex · General & Plastic Surgery device
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Sep 1985
Decision
193d
Days
Class 2
Risk

K850946 is an FDA 510(k) clearance for the SURGICAL ASPIRATOR. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Medicalex (Paris 75013, FR). The FDA issued a Cleared decision on September 16, 1985 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medicalex devices

FDA 510(k) Submission Details - K850946

510(k) Number K850946 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 07, 1985
Decision Date September 16, 1985
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
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 K850946.
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