510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834535Substantially Equivalent

Nitrous Oxide Recycler

G & L Unltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834535 is the FDA 510(k) clearance record for NITROUS OXIDE RECYCLER, a class I device, cleared for G & L Unltd. on under FDA product code BSF (Absorber, Carbon-Dioxide). FDA records list one 510(k) clearance for G & L Unltd. As of , FDA records show no recalls naming K834535.

Clearance record

Decision date
Received
(168 days to decision)
Product code
BSF Absorber, Carbon-Dioxide
Regulation
21 CFR 868.5310
Device class
Class I
Review panel
Anesthesiology
Applicant
G & L Unltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BSF

Trailing 12 months

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

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