Cleared Traditional

K942350 - CAREPAK

K942350 is an FDA 510(k) clearance for CAREPAK, manufactured by Precision Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K942350 · Precision Medical, Inc. · Anesthesiology device
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Dec 1994
Decision
203d
Days
Class 2
Risk

K942350 is an FDA 510(k) clearance for the CAREPAK. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on December 6, 1994 after a review of 203 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Precision Medical, Inc. devices

FDA 510(k) Submission Details - K942350

510(k) Number K942350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1994
Decision Date December 06, 1994
Days to Decision 203 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 140d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 190
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K942350.
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K961476 · Salter Labs · Jul 1996
JET NEBULIZER
K952249 · Devilbiss Health Care, Inc. · Jan 1996
DEVILBISS MODEL 5500
K946095 · Devilbiss Health Care, Inc. · Aug 1995
UNIHEART
K943600 · Vortran Medical Technology 1, Inc. · Oct 1994
AUTONEB ACCESSORY CROSS (AAC)
K944643 · Vortran Medical Technology 1, Inc. · Oct 1994
AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
K935693 · Vortran Medical Technology 1, Inc. · Aug 1994