Cleared Traditional

K031647 - BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

K031647 is an FDA 510(k) clearance for BIOSIGN SSI BIOLOGICAL TEST PACK WITH I..., manufactured by Getinge USA, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K031647 · Getinge USA, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
63d
Days
Class 2
Risk

K031647 is an FDA 510(k) clearance for the BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Getinge USA, Inc. (Rochester, US). The FDA issued a Cleared decision on July 29, 2003 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Getinge USA, Inc. devices

FDA 510(k) Submission Details - K031647

510(k) Number K031647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date July 29, 2003
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 208
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K031647.
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · Spsmedical Supply Corp. · Jun 2004
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K040742 · Advanced Sterilization Products · Apr 2004
MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
K032801 · Albert Browne , Ltd. · Oct 2003
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR
K030680 · Spsmedical Supply Corp. · May 2003
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
K022441 · Advanced Sterilization Products · Oct 2002
STEAMPLUS STERILIZATION TEST
K020409 · Spsmedical Supply Corp. · Jul 2002