Cleared Traditional

K810158 - DAVOL SILICONE SHEATH SUMP DRAIN

K810158 is an FDA 510(k) clearance for DAVOL SILICONE SHEATH SUMP DRAIN, manufactured by C.R. Bard, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBS cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K810158 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1981
Decision
23d
Days
Class 1
Risk

K810158 is an FDA 510(k) clearance for the DAVOL SILICONE SHEATH SUMP DRAIN. Classified as Catheter, Ventricular, General & Plastic Surgery (product code GBS), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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.

FDA 510(k) Submission Details - K810158

510(k) Number K810158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1981
Decision Date February 13, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

GBS Device Classification - Class 1, General Controls

Product Code GBS Catheter, Ventricular, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBS Catheter, Ventricular, General & Plastic Surgery

All 26
Devices cleared under the same product code (GBS) and FDA review panel - the closest regulatory comparables to K810158.
ARGYLE MEDIASTINAL DRAIN
K822318 · Sherwood Medical Co. · Aug 1982
SIL-V-UR CHEST CATHETER
K813463 · C.R. Bard, Inc. · Feb 1982
DISPOSABLE THORACIC CATHETER
K813587 · Texas Medical Products, Inc. · Jan 1982
STERILE SILICONE TUBING
K810071 · Medspec Corp. · Feb 1981
ARGYLE SILICONE THORACIC CATHETER
K802318 · Sherwood Medical Co. · Oct 1980
K810158 · DAVOL SILICONE SHEATH SUMP DRAIN
Download PDF C.R. Bard, Inc.