Cleared Traditional

K864199 - SALTER LABS #4001 ORAL NASAL CO2 SAMPLI...

K864199 is an FDA 510(k) clearance for SALTER LABS #4001 ORAL NASAL CO2 SAMPLI..., manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K864199 · Salter Labs · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
106d
Days
Class 2
Risk

K864199 is an FDA 510(k) clearance for the SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Salter Labs devices

FDA 510(k) Submission Details - K864199

510(k) Number K864199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date February 10, 1987
Days to Decision 106 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 140d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 152
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K864199.
MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY
K874036 · Novametrix Medical Systems, Inc. · Nov 1987
OSCAR(TM) PB255 OXIMETER CAPNOMETER
K872760 · Datex Division Instrumentarium Corp. · Sep 1987
BIOCHEM 8090 CAPNOGRAPH
K871133 · Biochem International, Inc. · Apr 1987
MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA
K864903 · Salter Labs · Jan 1987
MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.
K864902 · Salter Labs · Jan 1987
MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA
K863883 · Salter Labs · Oct 1986