Cleared Traditional

K922212 - MDT CASTLE BIOSIGN TEST PACK

K922212 is an FDA 510(k) clearance for MDT CASTLE BIOSIGN TEST PACK, manufactured by Mdt Corp., Inc.. The device is a Class 2 General Hospital device with product code FRC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K922212 · Mdt Corp., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
90d
Days
Class 2
Risk

K922212 is an FDA 510(k) clearance for the MDT CASTLE BIOSIGN TEST PACK. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on August 10, 1992 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Mdt Corp., Inc. devices

FDA 510(k) Submission Details - K922212

510(k) Number K922212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1992
Decision Date August 10, 1992
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 124
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K922212.
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
STERRAD BI TEST PACK
K921909 · Johnson & Johnson Medical, Inc. · Oct 1993
SPORVIEW
K905425 · Spsmedical Supply Corp. · Mar 1992
ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR
K900771 · 3M Company · Jul 1990
SPORVIEW CULTURE MEDIA
K890754 · Spsmedical Supply Corp. · Nov 1989