Cleared Traditional

K821265 - PNEUMOPULSSOR (PPS II)

K821265 is an FDA 510(k) clearance for PNEUMOPULSSOR (PPS II), manufactured by Strom Corp.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K821265 · Strom Corp. · Anesthesiology device
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Jul 1982
Decision
84d
Days
Class 2
Risk

K821265 is an FDA 510(k) clearance for the PNEUMOPULSSOR (PPS II). Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Strom Corp. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1982 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - 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.

FDA 510(k) Submission Details - K821265

510(k) Number K821265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1982
Decision Date July 26, 1982
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
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 - BYI Percussor, Powered-electric

All 46
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K821265.
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PERCUSSOR
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HAND PERCUSSOR CUP #65210
K802646 · B & F Medical Products, Inc. · Nov 1980
K821265 · PNEUMOPULSSOR (PPS II)
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