Cleared Traditional

K871616 - CUSTOM PROCEDURE TRAYS

K871616 is an FDA 510(k) clearance for CUSTOM PROCEDURE TRAYS, manufactured by Medical Custom Products, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K871616 · Medical Custom Products, Inc. · General Hospital
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Dec 1987
Decision
228d
Days
Class 2
Risk

K871616 is an FDA 510(k) clearance for the CUSTOM PROCEDURE TRAYS. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medical Custom Products, Inc. (East Haven, US). The FDA issued a Cleared decision on December 11, 1987 after a review of 228 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Custom Products, Inc. devices

FDA 510(k) Submission Details - K871616

510(k) Number K871616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 27, 1987
Decision Date December 11, 1987
Days to Decision 228 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
99d slower than avg
Panel avg: 129d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 544
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K871616.
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988
MEDSURG MYELOGRAM TRAY
K880693 · Medsurg Industries, Inc. · May 1988
ALLERGIST SYRINGES
K880894 · Abco Dealers, Inc. · Mar 1988
JMS NEEDLES AND JMS SYRINGES
K871965 · Jms Co., Ltd. · Sep 1987
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
LOOK SPRING-ASSIST SYRINGES
K872944 · Look, Inc. · Sep 1987