Cleared Traditional

K921909 - STERRAD BI TEST PACK

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

K921909 · Johnson & Johnson Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 114
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K921909.
STERRAD BI TEST PACK
K993775 · Advanced Sterilization Products · Jun 2000
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · Advanced Sterilization Products · Jun 1999
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K926364 · 3M Health Care, Ltd. · Mar 1995
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
ATI DISPOSABLE BIOLOGICAL TEST PACK
K855120 · Parke-Davis Co. · Jun 1986
CHEMSPOR
K844479 · American Sterilizer Co. · Nov 1985