Cleared Traditional

K904598 - ACCU PATH STERILE LABEL

K904598 · Accu-Path · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
20d
Days
-
Risk

K904598 is an FDA 510(k) clearance for the ACCU PATH STERILE LABEL.

Submitted by Accu-Path (Lilburn, US). The FDA issued a Cleared decision on October 30, 1990 after a review of 20 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 Accu-Path devices

FDA 510(k) Submission Details - K904598

510(k) Number K904598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1990
Decision Date October 30, 1990
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 40
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K904598.
NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
K925588 · North American Sterilization & Packaging Co. · Dec 1993
NORTEC STERILE WATER FOR DEVICE IRRIGATION
K925593 · North American Sterilization & Packaging Co. · Dec 1993
OLYMPIC WARMETTE
K911955 · Olympic Medical Corp. · Jul 1991
GLOVE LEAK DETECTOR
K901237 · Utah Medical Products, Inc. · Aug 1990
SARNS MEDICAL CART
K892052 · 3M Company · Jun 1989
BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE
K874186 · Busse Hospital Disposables, Inc. · Dec 1987