Cleared Traditional

K823058 - DOSOMETRIC RELEASE STERILIZATION

K823058 · Stan-Pak Ent. · General & Plastic Surgery device

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Dec 1982

Decision

52d

Days

Risk

K823058 is an FDA 510(k) clearance for the DOSOMETRIC RELEASE STERILIZATION. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Stan-Pak Ent. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Stan-Pak Ent. devices

FDA 510(k) Submission Details - K823058

510(k) Number	K823058 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 18, 1982
Decision Date	December 09, 1982
Days to Decision	52 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

63d faster than avg

Panel avg: 115d · This submission: 52d

Pathway characteristics

Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code	EFQ Gauze/sponge, Internal
Device Class	-

Regulatory Peers - EFQ Gauze/sponge, Internal

All 156

Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K823058.

FLORET DRAIN/TRACHEOTOMY SPONGE

K830265 · Ritmed, Inc. · Mar 1983

FLORET GAUZE PACKING

K830278 · Ritmed, Inc. · Mar 1983

FLORET PEANUT SPONGE/STICK & GAUZE PREP

K830274 · Ritmed, Inc. · Mar 1983

NU-GAUZE SPONGE

K821150 · Johnson & Johnson Professionals, Inc. · Aug 1982

X-RAY GUAZE SPONGES

K820106 · Stan-Pak Ent. · Feb 1982

GUAZE SPONGES, PLAIN

K820107 · Stan-Pak Ent. · Feb 1982

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K823058

Stan-Pak Ent.

Mchenry, IL · US

Regulatory profile

20 submissions 20 cleared

100% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: December 9, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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