Cleared Traditional

K863703 - SALTER LABS MODEL 4000 NASAL CO2 SAMPLE...

K863703 is an FDA 510(k) clearance for SALTER LABS MODEL 4000 NASAL CO2 SAMPLE..., 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 22-day FDA review.

K863703 · Salter Labs · Anesthesiology device
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Oct 1986
Decision
22d
Days
Class 2
Risk

K863703 is an FDA 510(k) clearance for the SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE. 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 October 15, 1986 after a review of 22 days - a notably fast clearance cycle.

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: 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 Salter Labs devices

FDA 510(k) Submission Details - K863703

510(k) Number K863703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date October 15, 1986
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 K863703.
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
MODIFIED GAS SAMPLING KIT
K863640 · Respiratory Support Products, Inc. · Oct 1986
MODULAR MASS SPECTROMETER (M.S.)
K862605 · The Perkin-Elmer Corp. · Aug 1986
DYNEX CO2/2000, CO2 ANALYZER
K862543 · Analytical Products, Inc. · Jul 1986