510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891388Substantially Equivalent

1570 - Fetal Blood Sampling Kit

Transidyne General Corp., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891388 is the FDA 510(k) clearance record for 1570 - FETAL BLOOD SAMPLING KIT, a class II device, cleared for Transidyne General Corp. on under FDA product code HGW (Sampler, Blood, Fetal). FDA records list 21 510(k) clearances for Transidyne General Corp., from to . As of , FDA records show no recalls naming K891388.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HGW Sampler, Blood, Fetal
Regulation
21 CFR 884.1560
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Transidyne General Corp. 3711 Plz. Dr., #4, Ann Arbor MI
Third party review
No

Clearances, product code HGW

Trailing 12 months

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

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