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
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K031647Substantially Equivalent

Biosign Ssi Biological Test Pack with Instant Readout Integrator

Getinge USA, Inc., Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031647 is the FDA 510(k) clearance record for BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, a class II device, cleared for Getinge USA, Inc. on under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process). FDA records list 4 510(k) clearances for Getinge USA, Inc., from to . As of , FDA records show no recalls naming K031647.

Clearance record

Decision date
Received
(63 days to decision)
Product code
JOJ Indicator, Physical/Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOJ

Trailing 12 months
3 clearances under product code JOJ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOJ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260