Cleared Traditional

K935621 - CUSTOM ENT PACKS

K935621 is an FDA 510(k) clearance for CUSTOM ENT PACKS, manufactured by Associated Medical. The device is a Class 1 General & Plastic Surgery device with product code LRP cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K935621 · Associated Medical · General & Plastic Surgery device
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Mar 1994
Decision
128d
Days
Class 1
Risk

K935621 is an FDA 510(k) clearance for the CUSTOM ENT PACKS. Classified as Tray, Surgical (product code LRP), Class I - General Controls.

Submitted by Associated Medical (Minnetonka, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Associated Medical devices

FDA 510(k) Submission Details - K935621

510(k) Number K935621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1993
Decision Date March 30, 1994
Days to Decision 128 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

LRP Device Classification - Class 1, General Controls

Product Code LRP Tray, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRP Tray, Surgical

All 11
Devices cleared under the same product code (LRP) and FDA review panel - the closest regulatory comparables to K935621.
LACERATION TRAY
K963723 · Grand Medical Products · Nov 1996
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK
K951811 · Osteotech, Inc. · May 1995
EYE TRAY
K940239 · Cush Medical Products · Jun 1994
GENERAL SURGERY TRAY
K940444 · Cush Medical Products · Mar 1994
EYE TRAY
K912105 · Medical Device Inspection Co., Inc. · Aug 1991
SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
K883098 · Site Microsurgical Systems, Inc. · Aug 1988