Cleared Traditional

K862628 - BUNN MODEL 510 MEDICATION COMPRESSOR

K862628 is an FDA 510(k) clearance for BUNN MODEL 510 MEDICATION COMPRESSOR, manufactured by The John Bunn Co.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K862628 · The John Bunn Co. · Anesthesiology device
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Aug 1986
Decision
28d
Days
Class 2
Risk

K862628 is an FDA 510(k) clearance for the BUNN MODEL 510 MEDICATION COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by The John Bunn Co. (Tonawanda, US). The FDA issued a Cleared decision on August 7, 1986 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - the FDA anesthesiology and respiratory 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 The John Bunn Co. devices

FDA 510(k) Submission Details - K862628

510(k) Number K862628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1986
Decision Date August 07, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BTI Compressor, Air, Portable

All 30
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K862628.
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