Cleared Traditional

K925749 - KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR

K925749 is an FDA 510(k) clearance for KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K925749 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
80d
Days
Class 1
Risk

K925749 is an FDA 510(k) clearance for the KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on February 1, 1993 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K925749

510(k) Number K925749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1992
Decision Date February 01, 1993
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
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 - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

All 51
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K925749.
ORC TAPPERED IRRIGATING PROBE
K925024 · O.R. Concepts, Inc. · May 1993
# 9455 AND #9457 POOLE TIP SUCTION PROBE
K923908 · O.R. Concepts, Inc. · May 1993
KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR
K925989 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1993
J-VAC BULB SUCTION RESERVOIR
K922895 · Johnson & Johnson Medical, Inc. · Sep 1992
DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
K915536 · Davol, Inc. · Mar 1992
CLOSED WOUND RESERVOIR
K896803 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989