Cleared Traditional

K872141 - CENTURION SPECIMEN TRAP W/CATHETER

K872141 is an FDA 510(k) clearance for CENTURION SPECIMEN TRAP W/CATHETER, manufactured by Tri-State Hospital Supply Corp.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K872141 · Tri-State Hospital Supply Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
85d
Days
Class 1
Risk

K872141 is an FDA 510(k) clearance for the CENTURION SPECIMEN TRAP W/CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on August 26, 1987 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - the FDA anesthesiology and respiratory 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 Tri-State Hospital Supply Corp. devices

FDA 510(k) Submission Details - K872141

510(k) Number K872141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1987
Decision Date August 26, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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 - BSY Catheters, Suction, Tracheobronchial

All 65
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K872141.
PEDIATRIC BUBBLE TRAP CAT. NO. B-100
K873610 · American Omni Medical, Inc. · Nov 1987
TRACH CARE START KIT
K873732 · Ballard Medical Products · Oct 1987
TRACH CARE CATHETER
K872621 · Ballard Medical Products · Sep 1987
JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
K872917 · American Pharmaseal Div. Ahsc · Aug 1987
ORAL SUCTION CATHETER
K872283 · Ballard Medical Products · Aug 1987
MECONIUM SUCTION CATHETER
K871825 · Concord Laboratories, Inc. · Jun 1987