Cleared Traditional

K820147 - STERI-SHURE

K820147 is an FDA 510(k) clearance for STERI-SHURE, manufactured by General Health Systems, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K820147 · General Health Systems, Inc. · General Hospital
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Feb 1982
Decision
17d
Days
Class 2
Risk

K820147 is an FDA 510(k) clearance for the STERI-SHURE. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by General Health Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1982 after a review of 17 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 General Health Systems, Inc. devices

FDA 510(k) Submission Details - K820147

510(k) Number K820147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1982
Decision Date February 05, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
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 170
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K820147.
CASTLE TEC-TEST S.M.A.R.T. PACK
K833074 · Castle Co. · Nov 1983
CHEMDI STEAM & GAS STERILIZATION INDICA
K823074 · American Sterilizer Co. · Nov 1982
GAS CHEX PLASTIC BAG
K821648 · Propper Mfg. Co., Inc. · Jun 1982
PROTECT-O-SEAL
K813014 · Tri-Med, Inc. · Nov 1981
CHEMICAL AUTOCLAVE INDICATOR TAPE
K811936 · American Hospital Supply Corp. · Jul 1981
CASTLE STEAM STERILIZATION INDICATOR
K810614 · Sybron Corp. · Jun 1981