510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921803Substantially Equivalent

Sofnolime Carbon Dioxide Absorbent

Molecular Products Inc, Thaxted, Essex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921803 is the FDA 510(k) clearance record for SOFNOLIME CARBON DIOXIDE ABSORBENT, a class I device, cleared for Molecular Products , Ltd. on under FDA product code CBL (Absorbent, Carbon-Dioxide). FDA records list 4 510(k) clearances for Molecular Products , Ltd., from to . As of , FDA records show no recalls naming K921803.

Clearance record

Decision date
Received
(183 days to decision)
Product code
CBL Absorbent, Carbon-Dioxide
Regulation
21 CFR 868.5300
Device class
Class I
Review panel
Anesthesiology
Applicant
Molecular Products , Ltd. Mill End, Thaxted, Essex, GB
510(k) summary
Statement
Third party review
No

Clearances, product code CBL

Trailing 12 months

FDA records hold no clearances under product code CBL in the trailing twelve months.

FDA records show no clearances under product code CBL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260