Cleared Traditional

K921988 - LACERATION REPAIR TRAY

K921988 is an FDA 510(k) clearance for LACERATION REPAIR TRAY, manufactured by Cypress Medical Products, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K921988 · Cypress Medical Products, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
205d
Days
Class 1
Risk

K921988 is an FDA 510(k) clearance for the LACERATION REPAIR TRAY. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on November 19, 1992 after a review of 205 days - an extended review cycle.

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 Cypress Medical Products, Ltd. devices

FDA 510(k) Submission Details - K921988

510(k) Number K921988 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 28, 1992
Decision Date November 19, 1992
Days to Decision 205 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
90d slower than avg
Panel avg: 115d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

Product Code MDM Instrument, Manual, Surgical, General Use
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 - MDM Instrument, Manual, Surgical, General Use

All 7
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K921988.
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · Boston Scientific Corp · Nov 2002
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
K981579 · Ethicon, Inc. · Jul 1998
ORC ENDOSCOPIC INSTRUMENT HOLDER
K930399 · O.R. Concepts, Inc. · Feb 1993
QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER
K911369 · Deroyal Industries, Inc. · May 1991
QUALTEX SUTURE BOOTIES
K911895 · Deroyal Industries, Inc. · May 1991
YANKAUER SUCTION DEVICE
K905478 · Medovations, Inc. · Dec 1990