Cleared Traditional

K880548 - SAFE-STRIPS

K880548 is an FDA 510(k) clearance for SAFE-STRIPS, manufactured by Medstar, Inc.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K880548 · Medstar, Inc. · General Hospital
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Sep 1988
Decision
233d
Days
Class 2
Risk

K880548 is an FDA 510(k) clearance for the SAFE-STRIPS. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Medstar, Inc. (Glenview, US). The FDA issued a Cleared decision on September 29, 1988 after a review of 233 days - an extended review 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: 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 Medstar, Inc. devices

FDA 510(k) Submission Details - K880548

510(k) Number K880548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date September 29, 1988
Days to Decision 233 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
104d slower than avg
Panel avg: 129d · This submission: 233d
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 224
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K880548.
LABEL, STERILIZATION INDICATOR
K890763 · Spsmedical Supply Corp. · Aug 1989
LABEL, STERILIZATION INDICATOR
K890764 · Spsmedical Supply Corp. · Aug 1989
STRIP, STERILIZATION INDICATOR
K890765 · Spsmedical Supply Corp. · Aug 1989
BIO-CHALLENGE TEST PAK
K851804 · Propper Mfg. Co., Inc. · Jul 1985
DART DAILY AIR REMOVAL TEST
K844512 · American Sterilizer Co. · Mar 1985
STERILIZATION PROCESS INDICATOR
K841168 · Parke-Davis Co. · May 1984