Cleared Traditional

K901920 - PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE

K901920 is an FDA 510(k) clearance for PRIME CARE NEONATAL/PEDIATRIC TRACHEOST..., manufactured by Primecare, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K901920 · Primecare, Inc. · Anesthesiology device
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Aug 1990
Decision
109d
Days
Class 2
Risk

K901920 is an FDA 510(k) clearance for the PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Primecare, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on August 17, 1990 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K901920

510(k) Number K901920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date August 17, 1990
Days to Decision 109 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
31d faster than avg
Panel avg: 140d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTO Tube, Tracheostomy (w/wo Connector)

All 91
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K901920.
TRACHEOSTOMY TUBE AND CUFF
K912124 · Concord/Portex · Aug 1991
BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
K912469 · Bivona Medical Technologies · Jun 1991
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
K903730 · Concord/Portex · Sep 1990
MODIFIED SCOOP TRANSTRACHEAL CATHETERS
K902281 · Transtracheal Systems · Aug 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
K901078 · L H M Ent., Inc. · May 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
K901079 · L H M Ent., Inc. · May 1990
K901920 · PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE
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