Cleared Traditional

K150603 - Rusch Safety Silk Pediatric Series Oral...

K150603 is an FDA 510(k) clearance for Rusch Safety Silk Pediatric Series Oral..., manufactured by Teleflexmedical, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K150603 · Teleflexmedical, Inc. · Anesthesiology device
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Nov 2015
Decision
262d
Days
Class 2
Risk

K150603 is an FDA 510(k) clearance for the Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on November 27, 2015 after a review of 262 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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.

View all Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K150603

510(k) Number K150603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date November 27, 2015
Days to Decision 262 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 140d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 149
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K150603.
Endotracheal tube
K170234 · Zhanjiang Star Enterprise Co., Ltd. · Jan 2018
IRRIS (Infra-Red-Red Intubation System)
K171411 · A.R Guide IN Medical , Ltd. · Jan 2018
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
K151381 · Covidien · Dec 2015
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT
K141939 · Teleflexmedical, Inc. · Nov 2014
RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE
K132415 · Teleflexmedical, Inc. · Jun 2014
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
K131254 · Kimberly-Clark Corp. · Aug 2013