Cleared Traditional

K853095 - BOEHRINGER LABORATORIES SUCTION INTERMI...

K853095 is the FDA 510(k) clearance for BOEHRINGER LABORATORIES SUCTION INTERMI... by Boehringer Laboratories. It is a Class 2 General Hospital device (product code GCX) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K853095 · Boehringer Laboratories · General Hospital
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Aug 1985
Decision
31d
Days
Class 2
Risk

K853095 is an FDA 510(k) clearance for the BOEHRINGER LABORATORIES SUCTION INTERMITTOR. Classified as Apparatus, Suction, Operating-room, Wall Vacuum Powered (product code GCX), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on August 23, 1985 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 Boehringer Laboratories devices

Submission Details

510(k) Number K853095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date August 23, 1985
Days to Decision 31 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 Hospital devices follow this clearance model.

Regulatory Peers - GCX Apparatus, Suction, Operating-room, Wall Vacuum Powered

All 39
Devices cleared under the same product code (GCX) and FDA review panel - the closest regulatory comparables to K853095.
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ACCURATE MEASUREMENT DEVICE EZ-AMD
K833673 · Sorensen Research · Dec 1983