510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001430Substantially Equivalent

Respirtech Pro-O2c, Model 2200 and Respirtech Pro, Model 2000

Vortran Medical Technology 1, Inc, Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001430 is the FDA 510(k) clearance record for RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000, a class II device, cleared for Vortran Medical Technology 1, Inc. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 28 510(k) clearances for Vortran Medical Technology 1, Inc., from to . As of , FDA records show 2 recalls naming K001430.

Clearance record

Decision date
Received
(61 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Vortran Medical Technology 1, Inc. 3941 J St., Sacramento CA
510(k) summary
Summary
Third party review
No

Clearances, product code BTL

Trailing 12 months

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

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