510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K935126Substantially Equivalent

Nascor Igloo

Nascor Pty., Ltd., Sydney Nsw, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935126 is the FDA 510(k) clearance record for NASCOR IGLOO, a class I device, cleared for Nascor Pty. , Ltd. on under FDA product code BYL (Tent, Oxygen). FDA records list 2 510(k) clearances for Nascor Pty. , Ltd., from to . As of , FDA records show no recalls naming K935126.

Clearance record

Decision date
Received
(355 days to decision)
Product code
BYL Tent, Oxygen
Regulation
21 CFR 868.5700
Device class
Class I
Review panel
Anesthesiology
Applicant
Nascor Pty. , Ltd. P.O. Box 141 Beverly Hills Nsw, Sydney Nsw, AU
510(k) summary
Statement
Third party review
No

Clearances, product code BYL

Trailing 12 months

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

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