Cleared Traditional

K843644 - STORZ ASPIRATION MACHINE SAM 5000

K843644 is the FDA 510(k) clearance for STORZ ASPIRATION MACHINE SAM 5000 by Storz Instrument Co.. It is a Class 2 General & Plastic Surgery device (product code BTA) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K843644 · Storz Instrument Co. · General & Plastic Surgery device
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Nov 1984
Decision
60d
Days
Class 2
Risk

K843644 is an FDA 510(k) clearance for the STORZ ASPIRATION MACHINE SAM 5000. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on November 16, 1984 after a review of 60 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 Storz Instrument Co. devices

Submission Details

510(k) Number K843644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date November 16, 1984
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K843644.
PM PUMP ASPIRATOR
K932494 · Precision Medical, Inc. · Oct 1993
VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · Jedmed Instrument Co. · Mar 1991
HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)
K862569 · Jedmed Instrument Co. · Aug 1986
BRONCHOSCOPE SUCTION UNIT
K841399 · Keymed, Inc. · Jul 1984
CONNECTING TUBES
K831007 · Medovations, Inc. · May 1983
KEYMED KEY VAC SUCTION PUMP
K820739 · Keymed, Inc. · May 1982