510(k) · Cleared

Cleared

C2 CryoBalloon EndoGrip

K193036510(k) SpecialCleared Nov 22, 201922-day reviewClass II21 CFR 876.1500

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

Pentax Medical, A Division of Pentax of America, Inc. · OCX Endoscopic Irrigation/Suction System

Cleared on Nov 22, 2019 as substantially equivalent to K152140 (C2 Therapeutics, Inc., 2015) after a 22-day review. Its family tree reaches back 2 generations to 2011.

Decided: Nov 22, 2019
Review: 22 days
Class: Class II
Product code: OCX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K111821 (2011). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK111821 Biopsy ValveEndochoice, Inc. · 2011
1 generation backK152140 Boa Endoscopic ValveC2 Therapeutics, Inc. · 2015
This deviceK193036 C2 CryoBalloon EndoGripPentax Medical, A Division of Pentax of America, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K111821	Biopsy Valve	Endochoice, Inc.	2011	—
−1	K152140	Boa Endoscopic Valve	C2 Therapeutics, Inc.	2015	—
0 (this device)	K193036	C2 CryoBalloon EndoGrip	Pentax Medical, A Division of Pentax of America, Inc.	2019	—

FIG. 1 — Lineage of K193036, 2011–2019Source: 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 OCX? 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 OCX device

#1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K152140	Boa Endoscopic Valve Summary page 4 …sories Classification Code: 21 CFR §876.1500 Regulatory Class: Class II Product Code: OCX III. PREDICATE DEVICE BOA Endoscopic Valve (K152140) This predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The C2 CryoBal…	C2 Therapeutics, Inc.	2015	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All OCX devices

OCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · OCX

4in 2025

2007high 8 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCX

178in 2025

2007high 256 (2012) · low 51 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCX

2in 2022

2007high 11 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCX

33in 2025

2007high 46 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCX, 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	1
2009	1	—	0	0
2010	3	51	0	0
2011	1	—	0	0
2012	4	256	0	1
2013	3	106	0	1
2014	6	77	0	5
2015	2	—	1	9
2016	2	—	0	8
2017	0	—	0	9
2018	5	60	0	18
2019	8	133	0	41
2020	4	88	11	11
2021	3	233	0	8
2022	6	84	2	18
2023	7	109	0	46
2024	4	74	0	21
2025	4	178	0	33
2026	0	—	2	—

What is it indicated for?

The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K193036 · printed Nov 4, 2026

Cite this page

510(k) Report. “K193036: C2 CryoBalloon EndoGrip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193036

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026