Cleared Traditional

K952062 - PFT FILTER

K952062 is an FDA 510(k) clearance for PFT FILTER, manufactured by Intertech Resources, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K952062 · Intertech Resources, Inc. · General Hospital
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Jun 1995
Decision
37d
Days
Class 2
Risk

K952062 is an FDA 510(k) clearance for the PFT FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on June 8, 1995 after a review of 37 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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K952062

510(k) Number K952062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1995
Decision Date June 08, 1995
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
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 74
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K952062.
AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp. · Jun 2001
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996
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