Cleared Traditional

K991108 - CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01

K991108 is an FDA 510(k) clearance for CARBON DIOXIDE (CO2), manufactured by A.P. Total Care, Inc.. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K991108 · A.P. Total Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
54d
Days
Class 2
Risk

K991108 is an FDA 510(k) clearance for the CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on May 25, 1999 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - the FDA in vitro diagnostics and chemistry 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 A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K991108

510(k) Number K991108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date May 25, 1999
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
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: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHS Device Classification - Class 2, Special Controls

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 Chemistry devices follow this clearance model.

Regulatory Peers - KHS Enzymatic, Carbon-dioxide

All 78
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K991108.
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · Diagnostic Chemicals , Ltd. · Sep 2000
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
K001133 · Ortho-Clinical Diagnostics, Inc. · Apr 2000
CARESIDE CO2, TOTAL
K992475 · Careside, Inc. · Sep 1999
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754 · Diagnostic Chemicals , Ltd. · Apr 1999
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
K983019 · Diagnostic Chemicals , Ltd. · Sep 1998
RAICHEM CO2 REAGENT
K982056 · Reagents Applications, Inc. · Jun 1998