Cleared Traditional

K862132 - HCI MECONIUM ASPIRATOR

K862132 is an FDA 510(k) clearance for HCI MECONIUM ASPIRATOR, manufactured by Hospital Concepts, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K862132 · Hospital Concepts, Inc. · Anesthesiology device
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Jun 1986
Decision
15d
Days
Class 1
Risk

K862132 is an FDA 510(k) clearance for the HCI MECONIUM ASPIRATOR. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Hospital Concepts, Inc. (Burbank, US). The FDA issued a Cleared decision on June 19, 1986 after a review of 15 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.

FDA 510(k) Submission Details - K862132

510(k) Number K862132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1986
Decision Date June 19, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 140d · This submission: 15d
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 71
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K862132.
GESCO ASPIRATOR
K870962 · Gesco Intl., Inc. · May 1987
TRACHEOBRONCHIAL SUCTION CATHETER
K864468 · Sheridan Catheter Corp. · Jan 1987
TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
K864535 · Concord Laboratories, Inc. · Jan 1987
TRACHEOBRONCHIAL SUCTION CATHETER
K860802 · Sheridan Catheter Corp. · Apr 1986
ACKRAD ORAL SUCTION TUBE
K854320 · Ackrad Laboratories · Jan 1986
VYGON DELEE SUCTION CATHETER CODE NO 533
K851473 · Vygon Corp. · Jul 1985