510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981726Substantially Equivalent

Percussivetech HF, Model 2001

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

K981726 is the FDA 510(k) clearance record for PERCUSSIVETECH HF, MODEL 2001, a class II device, cleared for Vortran Medical Technology 1, Inc. on under FDA product code NHJ (Device, Positive Pressure Breathing, Intermittent). FDA records list 28 510(k) clearances for Vortran Medical Technology 1, Inc., from to . As of , FDA records show no recalls naming K981726.

Clearance record

Decision date
Received
(125 days to decision)
Product code
NHJ Device, Positive Pressure Breathing, Intermittent
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Vortran Medical Technology 1, Inc. 3941 J St., Sacramento CA
510(k) summary
Statement
Third party review
No

Clearances, product code NHJ

Trailing 12 months
2 clearances under product code NHJ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NHJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260