510(k) · Cleared

Cleared

Patil Emergency Cricothyrotomy Catheter Set

K013252510(k) TraditionalCleared Feb 21, 2002146-day reviewClass II21 CFR 868.5090

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook, Inc. · BWC Needle, Emergency Airway

Cleared on Feb 21, 2002 as substantially equivalent to K010016 (Cook, Inc., 2001) and 1 other predicate after a 146-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Feb 21, 2002
Review: 146 days
Class: Class II
Product code: BWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K914743 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK914743 Emergency Percutaneous Cricothyroidotomy Kit,ModifPertrach · 1992
This deviceK013252 Patil Emergency Cricothyrotomy Catheter SetCook, Inc. · 2002
Descendant · cites it directly · 0 of its ownK153761 Emergency Transtracheal Airway CatheterCook Incorporated · 2016

Most influential descendants

Showing 1 of 1 · See all

K153761Emergency Transtracheal Airway CatheterCook Incorporated · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914743	Emergency Percutaneous Cricothyroidotomy Kit,Modif	Pertrach	1992	—
0 (this device)	K013252	Patil Emergency Cricothyrotomy Catheter Set	Cook, Inc.	2002	—
+1	K153761	Emergency Transtracheal Airway Catheter	Cook Incorporated	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K013252, 1992–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BWC device

#1 K200190 ScalpelCricscore 0.6 · 2 generations · no Class I recall

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K010016	Melker Cuffed Emergency Cricothyrotomy Catheter Cleared while this submission was under review Summary page 1 …Cricothyroid Catheter Set Proposed Classification: Emergency Airway Needle Predicate Devices: Melker Cuffed Marketed & Distributed by Cricothyroid Catheter Cook Inc. (K010016) The Pertrach Marketed and Distributed by Pertrach Inc. (K914743) Device Description: The Patil Cricothyroid Catheter consists…	Cook, Inc.	2001	1
*	K914743	Emergency Percutaneous Cricothyroidotomy Kit,Modif Summary page 1 …way Needle Predicate Devices: Melker Cuffed Marketed & Distributed by Cricothyroid Catheter Cook Inc. (K010016) The Pertrach Marketed and Distributed by Pertrach Inc. (K914743) Device Description: The Patil Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an in…	Pertrach	1992	—

Also cleared against K010016: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K153761	Emergency Transtracheal Airway Catheter	Cook Incorporated	2016	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K153761 (Cook Incorporated, 2016) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K010016.

How does its category compare?

All BWC devices

BWC Needle, Emergency Airway: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BWC

1in 2020

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BWC

Too few BWC 510(k)s in any year since 2007 to give a median.

Recalls per year · BWC

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BWC

1in 2024

2007high 6 (2018) · low 0 (2007)2025

MAUDE reports naming product code BWC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	1
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	1	—	0	1
2014	0	—	0	1
2015	0	—	0	0
2016	1	—	0	2
2017	1	—	0	1
2018	0	—	0	6
2019	0	—	1 (1)	1
2020	1	—	0	0
2021	0	—	0	1
2022	0	—	0	4
2023	0	—	0	0
2024	0	—	0	1
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013252 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013252: Patil Emergency Cricothyrotomy Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013252

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026