Cleared Traditional

K871825 - MECONIUM SUCTION CATHETER

K871825 is an FDA 510(k) clearance for MECONIUM SUCTION CATHETER, manufactured by Concord Laboratories, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K871825 · Concord Laboratories, Inc. · Anesthesiology device
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Jun 1987
Decision
49d
Days
Class 1
Risk

K871825 is an FDA 510(k) clearance for the MECONIUM SUCTION CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Concord Laboratories, Inc. (Keene, US). The FDA issued a Cleared decision on June 29, 1987 after a review of 49 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 Concord Laboratories, Inc. devices

FDA 510(k) Submission Details - K871825

510(k) Number K871825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1987
Decision Date June 29, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
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 64
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K871825.
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 ASPIRATOR
K871407 · Intertech Resources, Inc. · Jun 1987
GESCO ASPIRATOR
K870962 · Gesco Intl., Inc. · May 1987
TRACHEOBRONCHIAL SUCTION CATHETER
K864468 · Sheridan Catheter Corp. · Jan 1987