Cleared Traditional

K943402 - K.P.R. (KING PERSONAL RESUSCITATOR)

K943402 is an FDA 510(k) clearance for K.P.R. (KING PERSONAL RESUSCITATOR), manufactured by King Systems Corp.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K943402 · King Systems Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
36d
Days
Class 2
Risk

K943402 is an FDA 510(k) clearance for the K.P.R. (KING PERSONAL RESUSCITATOR). Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on August 19, 1994 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 - K943402

510(k) Number K943402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1994
Decision Date August 19, 1994
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 90
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K943402.
RESCUE BREATHER
K940927 · O-Two Systems Intl., Inc. · Oct 1994
PROTECTAIDE CPR PROTECTION PACK NO. 17701
K942466 · Protectaide, Inc. · Oct 1994
PROTECTAIDE AVIATOR CPR PROTECTION PACK NO. 31000
K942467 · Protectaide, Inc. · Oct 1994
MOUTH TO MOUTH BREATHER
K942021 · Gam Industries, Inc. · Jun 1994
CPROTECTOR
K934821 · Certified Safety Mfg., Inc. · Jan 1994
MAGNASHIELD CPR MOUTH BARRIER
K933756 · Cal West Trading Co. · Jan 1994
K943402 · K.P.R. (KING PERSONAL RESUSCITATOR)
Download PDF FDA Summary King Systems Corp.