Cleared Traditional

K851315 - ABCO INSTRUMENT PACKS & TRAYS

K851315 is the FDA 510(k) clearance for ABCO INSTRUMENT PACKS & TRAYS by Abco Dealers, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K851315 · Abco Dealers, Inc. · General Hospital
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May 1985
Decision
29d
Days
Class 2
Risk

K851315 is an FDA 510(k) clearance for the ABCO INSTRUMENT PACKS & TRAYS. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on May 1, 1985 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K851315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1985
Decision Date May 01, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 118
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K851315.
DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP
K921490 · Trinity Laboratories, Inc. · Oct 1992
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
K881471 · Kimberly-Clark Corp. · Aug 1988
KIMGUARD PROCEDURE TRAY
K852203 · Kimberly-Clark Corp. · Jun 1985
BLUE SEAL II STERILIZATION POUCH
K851340 · American Sterilizer Co. · Apr 1985
TPN/HYPERALIMENTATION TRAY
K842644 · Deroyal Industries, Inc. · Nov 1984
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · Medline Industries, Inc. · Jul 1984