Cleared Traditional

K890570 - SKIN SCRUB KIT

K890570 is an FDA 510(k) clearance for SKIN SCRUB KIT, manufactured by Kit Pak, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K890570 · Kit Pak, Inc. · General & Plastic Surgery device
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May 1989
Decision
88d
Days
Class 2
Risk

K890570 is an FDA 510(k) clearance for the SKIN SCRUB KIT. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on May 5, 1989 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - the FDA general and plastic surgery 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 Kit Pak, Inc. devices

FDA 510(k) Submission Details - K890570

510(k) Number K890570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1989
Decision Date May 05, 1989
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 67
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K890570.
1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT
K895202 · Transidyne General Corp. · Sep 1989
DAVIS+GECK VISADUCT KIT
K894685 · Davis & Geck, Inc. · Aug 1989
BIOPSY KIT
K892389 · I M, Inc. · Jul 1989
SUTURE REMOVAL KIT
K890729 · Cypress Medical Products, Ltd. · Apr 1989
TRACHEOSTOMY CARE AND CLEANING KITS
K890726 · Cypress Medical Products, Ltd. · Mar 1989
HOMER MAMMALOK LOCALIZATION SHIELD
K885090 · North American Instrument Corp. · Feb 1989