Biosign Ssi Biological Test Pack with Instant Readout Integrator

Q: What is the product code of K031647?

The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.

FDA 510(k) K031647 · Getinge USA, Inc.

Substantially Equivalent

510(k) numberK031647

Submission

Device name: Biosign Ssi Biological Test Pack with Instant Readout Integrator
Applicant: Getinge USA, Inc.
Rochester, NY, US
Received: May 27, 2003
Decision date: July 29, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JOJ – Indicator, Physical/Chemical Sterilization Process
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.2800
Specialty: General Hospital

Other 510(k)s with product code JOJ

510(k)	Device	Applicant	Decision
K260181	LF Process Indicator Tape for Steam SterilizationJOJ · Special	Intertape Polymer Group	02/20/2026SE
K251991	SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…JOJ · Traditional	Shenzhen Safesecure Medical Infection Control…	12/23/2025SE
K251035	DISINTEK PA Test StripsJOJ · Traditional	Serim Research	06/03/2025SE
K251048	Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special	STERIS Corporation	05/02/2025SE
K243876	VERIFY STEAM Integrating IndicatorJOJ · Special	STERIS Corporation	04/25/2025SE
K250172	Green Card Bowie-Dick Test (BD115)JOJ · Special	Steritec Products, Inc. (A Getinge Company)	02/20/2025SE
K242860	Type 5 Integrating Indicator for Steam (CSPN-15)JOJ · Traditional	True Indicating, LLC	01/17/2025SE
K241036	Autoclave Indicator Tape; EO Indicator TapeJOJ · Traditional	Jiangmen New Era External Use Drug Co., Ltd.	12/17/2024SE
K243475	Chemical Indicator for enspire CLCSPS (LCC015)JOJ · Special	STERIS Corporation	12/04/2024SE
K242795	Getinge Assured MI Steam Migrating IntegratorJOJ · Special	Steritec Products Mfg. (A Getinge Group Company)	10/15/2024SE

More from Steritec Products Mfg. (A Getinge Group Company)

510(k)	Device	Decision
K050664	Spor-Test Pa Biological Indicator KitFRC · Special	04/07/2005SE
K032723	Biosign STEAM-24 Biological IndicatorFRC · Special	10/01/2003SE
K031259	Model 833HC Vacuum/Gravity Steam SterilizerFLE · Special	05/12/2003SE

Questions and answers

When was Biosign Ssi Biological Test Pack with Instant Readout Integrator cleared by the FDA?

Biosign Ssi Biological Test Pack with Instant Readout Integrator (K031647) received a 510(k) decision of Substantially Equivalent on July 29, 2003, 63 days after the submission was received.

What is the product code of K031647?

The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.