510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K043615Substantially Equivalent

Oxytec, Model 900

Oxytec Medical Corporation, Mccordsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043615 is the FDA 510(k) clearance record for OXYTEC, MODEL 900, a class II device, cleared for Oxytec Medical Corporation on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list one 510(k) clearance for Oxytec Medical Corporation. As of , FDA records show no recalls naming K043615.

Clearance record

Decision date
Received
(41 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Oxytec Medical Corporation 6329 W. Waterview Ct., Mccordsville IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAW

Trailing 12 months
12 clearances under product code CAW in the twelve months to October 2026, December 2025 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code CAW, trailing twelve months
MonthClearances
November 20251
December 20255
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260