510(k) · Cleared

Cleared

ENDOFLOW II - Irrigation, Warming and Suction System

K152278510(k) TraditionalCleared Feb 9, 2016181-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

Promepla Sam · OCX Endoscopic Irrigation/Suction System

Cleared on Feb 9, 2016 as substantially equivalent to K072080 (Smiths Medical Asd, Inc., 2008) and 2 other predicates after a 181-day review. Its family tree reaches back 4 generations to 1994. 2 of the 16 devices in its family, counting itself, have a Class I recall.

Decided: Feb 9, 2016
Review: 181 days
Class: Class II
Product code: OCX
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K933002 (1994). 15 ancestors in all, the oldest K873435 (1987). No later device cites it as a predicate yet. 2 of the 16 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
3 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
2 generations backK073207 Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments · 2008 · Recalled
1 generation backK113119 Endogator Advantage Irrigation PumpByrne Medical, Inc. · 2012
This deviceK152278 ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam · 2016

Class I recalls in this family

K072080 Normoflo Irrigation Fluid Warmer, Models H-1100…direct predicate · 2008
K973741 Bair Hugger Blood/Fluid Warmer3 generations back · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K933002	Erbotom Icc 350	Erbe USA, Inc.	1994	—
−3	K023886	Erbe Vio Esu with Accessories, Model Vio 300 D	Erbe USA, Inc.	2002	—
−2	K073207	Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167	Celon AG Medical Instruments	2008	1
−1	K113119	Endogator Advantage Irrigation Pump	Byrne Medical, Inc.	2012	—
0 (this device)	K152278	ENDOFLOW II - Irrigation, Warming and Suction System	Promepla Sam	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1988	1	0
1994	3	0
1995	1	0
1998	1	1
2000	1	0
2006	2	0
2008	1	1

FIG. 1 — Lineage of K152278, 1994–2016Source: 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.

2 devices in this family have a Class I recall. 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? (3)

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
*	K072080	Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming… Summary page 6 …on, Warming \| IRRIGATION FLUID \|[ADVANTAGE and Suction System \| WARMER, IRRIGATION PUMP Product Name Models MENOLUS \| MODEL H-1129 MODEL EGA-500 & MENO2PUS 510(k) Number K072080 K113119 K954465 Product Code 0CX LGZ ocX HRX Endoscopic Endoscopic Classification Name \| Irrigation/Suction Warmer, Th‘ermal, Irr…	Smiths Medical Asd, Inc.	2008	Class I
*	K113119	Endogator Advantage Irrigation Pump Summary page 6 …ing \| IRRIGATION FLUID \|[ADVANTAGE and Suction System \| WARMER, IRRIGATION PUMP Product Name Models MENOLUS \| MODEL H-1129 MODEL EGA-500 & MENO2PUS 510(k) Number K072080 K113119 K954465 Product Code 0CX LGZ ocX HRX Endoscopic Endoscopic Classification Name \| Irrigation/Suction Warmer, Th‘ermal, Irrigation/…	Byrne Medical, Inc.	2012	—
*	K954465	FMS Duo Summary page 6 …RIGATION FLUID \|[ADVANTAGE and Suction System \| WARMER, IRRIGATION PUMP Product Name Models MENOLUS \| MODEL H-1129 MODEL EGA-500 & MENO2PUS 510(k) Number K072080 K113119 K954465 Product Code 0CX LGZ ocX HRX Endoscopic Endoscopic Classification Name \| Irrigation/Suction Warmer, Th‘ermal, Irrigation/Suction…	Future Medical Systems, Inc.	1995	2

Also cleared against K072080: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40…Smiths Medical Asd, Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
6 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
3 other devices also cite its predicate K072080.

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. 2016, 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 ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.

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/K152278 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152278: ENDOFLOW II - Irrigation, Warming and Suction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152278

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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