510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901643Substantially Equivalent

Isoflo(tm) Amniocentesis Tray

Healthdyne Cardiovascular, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901643 is the FDA 510(k) clearance record for ISOFLO(TM) AMNIOCENTESIS TRAY, a class I device, cleared for Healthdyne Cardiovascular, Inc. on under FDA product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)). FDA records list 5 510(k) clearances for Healthdyne Cardiovascular, Inc., from to . As of , FDA records show no recalls naming K901643.

Clearance record

Decision date
Received
(107 days to decision)
Product code
HIO Sampler, Amniotic Fluid (Amniocentesis Tray)
Regulation
21 CFR 884.1550
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Healthdyne Cardiovascular, Inc. 45 Parker St., Suite A, Irvine CA
Third party review
No

Clearances, product code HIO

Trailing 12 months

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

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