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
K801087Substantially Equivalent

Neonatal Breathing Circuit System

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

K801087 is the FDA 510(k) clearance record for NEONATAL BREATHING CIRCUIT SYSTEM, a class I device, cleared for Isothermal Systems, Inc. on under FDA product code BZO (Set, Tubing And Support, Ventilator (W Harness)). FDA records list 2 510(k) clearances for Isothermal Systems, Inc., from to . As of , FDA records show no recalls naming K801087.

Clearance record

Decision date
Received
(16 days to decision)
Product code
BZO Set, Tubing And Support, Ventilator (W Harness)
Regulation
21 CFR 868.5975
Device class
Class I
Review panel
Anesthesiology
Applicant
Isothermal Systems, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BZO

Trailing 12 months

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

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