Cleared Traditional

K851407 - SURGICAL TOWELS

K851407 is an FDA 510(k) clearance for SURGICAL TOWELS, manufactured by Diack. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K851407 · Diack · General Hospital
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Jun 1985
Decision
59d
Days
Class 2
Risk

K851407 is an FDA 510(k) clearance for the SURGICAL TOWELS. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by Diack (Beulah, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 59 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 Diack devices

FDA 510(k) Submission Details - K851407

510(k) Number K851407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date June 07, 1985
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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 238
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K851407.
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
OK FLASH STERILIZATION INDICATOR
K834353 · Propper Mfg. Co., Inc. · Mar 1984