Cleared Traditional

K943874 - PRECISON THERMOPLASTIC COMPONENTS GAS A...

K943874 is the FDA 510(k) clearance for PRECISON THERMOPLASTIC COMPONENTS GAS A... by Precision Thermoplastic Components, Inc.. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K943874 · Precision Thermoplastic Components, Inc. · General Hospital
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Oct 1994
Decision
81d
Days
Class 2
Risk

K943874 is an FDA 510(k) clearance for the PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Precision Thermoplastic Components, Inc. (Lima, US). The FDA issued a Cleared decision on October 28, 1994 after a review of 81 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 Precision Thermoplastic Components, Inc. devices

Submission Details

510(k) Number K943874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1994
Decision Date October 28, 1994
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K943874.
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005
END EXPIRATORY FILTER, MODEL RT020
K002839 · Fisher &Paykel Healthcare , Ltd. · Oct 2001
BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
K951047 · Vital Signs, Inc. · Jun 1995
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217 · Merit Medical Systems, Inc. · Jan 1993
VENTILATOR CIRCUITS
K920885 · Vital Signs, Inc. · Oct 1992
BACTERIA FILTER
K912577 · Vital Signs, Inc. · Apr 1992