Cleared Traditional

K921909 - STERRAD BI TEST PACK

K921909 is an FDA 510(k) clearance for STERRAD BI TEST PACK, manufactured by Johnson & Johnson Medical, Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 526-day FDA review.

K921909 · Johnson & Johnson Medical, Inc. · General Hospital
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Oct 1993
Decision
526d
Days
Class 2
Risk

K921909 is an FDA 510(k) clearance for the STERRAD BI TEST PACK. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 526 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Johnson & Johnson Medical, Inc. devices

FDA 510(k) Submission Details - K921909

510(k) Number K921909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1992
Decision Date October 01, 1993
Days to Decision 526 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
397d slower than avg
Panel avg: 129d · This submission: 526d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRC Device Classification - Class 2, Special Controls

Product Code FRC Indicator, Biological 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 - FRC Indicator, Biological Sterilization Process

All 180
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K921909.
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · 3M Health Care, Ltd. · Mar 1995
ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK
K925496 · Pymah Corp. · Feb 1994
ATI(R) DISP BIOLOGICAL-PLUS TEST PACK
K925745 · Pymah Corp. · Feb 1994
MDT CASTLE BIOSIGN TEST PACK
K922212 · Mdt Corp., Inc. · Aug 1992
SPORVIEW
K905425 · Spsmedical Supply Corp. · Mar 1992
BI-O.K. STEAM TEST-PAK
K903024 · Propper Mfg. Co., Inc. · Sep 1990