Cleared Traditional

K841903 - FRASER HARLAKE EMERG. CARE SUCTION SYS

K841903 is the FDA 510(k) clearance for FRASER HARLAKE EMERG. CARE SUCTION SYS by Fraser Harlake, Inc.. It is a Class 2 General & Plastic Surgery device (product code BTA) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K841903 · Fraser Harlake, Inc. · General & Plastic Surgery device
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Jun 1984
Decision
38d
Days
Class 2
Risk

K841903 is an FDA 510(k) clearance for the FRASER HARLAKE EMERG. CARE SUCTION SYS. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Fraser Harlake, Inc. (Walker, US). The FDA issued a Cleared decision on June 14, 1984 after a review of 38 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 Fraser Harlake, Inc. devices

Submission Details

510(k) Number K841903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1984
Decision Date June 14, 1984
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 39
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K841903.
VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · Jedmed Instrument Co. · Mar 1991
HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)
K862569 · Jedmed Instrument Co. · Aug 1986
STORZ ASPIRATION MACHINE SAM 5000
K843644 · Storz Instrument Co. · Nov 1984
SYSTEC 280 INTEGRATED SUCTION SYSTEM
K791349 · Stryker Corp. · Sep 1979