510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841858Substantially Equivalent

Spiroloop

Datamed, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841858 is the FDA 510(k) clearance record for SPIROLOOP, a class II device, cleared for Datamed, Inc. on under FDA product code BSE (Analyzer, Gas, Helium, Gaseous-Phase). FDA records list 3 510(k) clearances for Datamed, Inc., from to . As of , FDA records show no recalls naming K841858.

Clearance record

Decision date
Received
(68 days to decision)
Product code
BSE Analyzer, Gas, Helium, Gaseous-Phase
Regulation
21 CFR 868.1640
Device class
Class II
Review panel
Anesthesiology
Applicant
Datamed, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BSE

Trailing 12 months

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

FDA records show no clearances under product code BSE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSE, 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