Cleared Traditional

K952015 - PRIMA FILTER

K952015 is an FDA 510(k) clearance for PRIMA FILTER, manufactured by Prima, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K952015 · Prima, Inc. · General Hospital
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May 1995
Decision
24d
Days
Class 2
Risk

K952015 is an FDA 510(k) clearance for the PRIMA FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Prima, Inc. (Cleveland, US). The FDA issued a Cleared decision on May 22, 1995 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - 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 Prima, Inc. devices

FDA 510(k) Submission Details - K952015

510(k) Number K952015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1995
Decision Date May 22, 1995
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 - CAH Filter, Bacterial, Breathing-circuit

All 108
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K952015.
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996
PFT FILTER
K952062 · Intertech Resources, Inc. · Jun 1995
BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
K951047 · Vital Signs, Inc. · Jun 1995
DISPOSABLE BACTERIAL BREATHNG FILTER
K915750 · Hospitak, Inc. · Nov 1994
SPIROBAC ADAPTERS
K944124 · Mallinckrodt Medical · Sep 1994
STERIVENT AND STERIVENT S
K941676 · Mallinckrodt Medical · May 1994