510(k) · Cleared

Cleared

Boehringer Laboratories Suction Pump System

K060277510(k) TraditionalCleared Mar 3, 200629-day reviewClass II21 CFR 878.4780

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

Boehringer Laboratories · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

Cleared on Mar 3, 2006 as substantially equivalent to K983552 (Medela, Inc., 1999) after a 29-day review. Its family tree reaches back 1 generation to 1999. 45 later devices descend from it.

Decided: Mar 3, 2006
Review: 29 days
Class: Class II
Product code: JCX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K983552 (1999). 45 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK983552 Basic, Median, Dominant, and VarioMedela, Inc. · 1999
This deviceK060277 Boehringer Laboratories Suction Pump SystemBoehringer Laboratories · 2006
Descendant · cites it directly · 37 of its ownK080275 NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008
Descendant · 2 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
Descendant · 2 generations on · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
Descendant · 3 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
Descendant · 3 generations on · 11 of its ownK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2006high 6 (2017) · low 0 (2007)2026

Most influential descendants

Showing 5 of 45 · See all

K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008 · cites it directly37descendants
K111170PICOSmith & Nephew, Inc. · 2011 · 2 generations on26descendants
K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · 2 generations on25descendants
K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 3 generations on23descendants
K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017 · 3 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K983552	Basic, Median, Dominant, and Vario	Medela, Inc.	1999	—
0 (this device)	K060277	Boehringer Laboratories Suction Pump System	Boehringer Laboratories	2006	—
+1	K080275	NPD 1000 Negative Pressure Wound Therapy System	Iasis Medical, Inc.	2008	—
+2	K111170	PICO	Smith & Nephew, Inc.	2011	—
+2	K112127	Pico Single Use Negative Pressure Wound Therapy System	Smith & Nephew, Inc.	2012	—
+3	K151436	PICO Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical, Ltd.	2016	—
+3	K163387	PICO Single Use Negative Pressure Wound Therapy System	Smith & Nephew Medical Limited	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	2	0
2011	1	0
2012	2	0
2013	1	0
2014	3	0
2016	5	0
2017	6	0
2018	5	0
2019	4	0
2020	3	0
2021	3	0
2022	4	0
2023	2	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K060277, 1999–2026Source: 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 JCX? 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 JCX device

#1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 4 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? (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
*	K983552	Basic, Median, Dominant, and Vario Summary page 1 …re Products Gomco Thermotic Drainage Pump Pre-amendment device Medela Suction Pumps Median and Vario K983552 Device Description: The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of lo…	Medela, Inc.	1999	—
*	—	Allied Healthcare Products Gomco Thermotic Drainage Pump Named without a submission number			—

Also cleared against K983552: 8 other devices →

What descends from it? (45)

See all 45

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080275	NPD 1000 Negative Pressure Wound Therapy System	Iasis Medical, Inc.	2008	37
K061788	Boehringer Laboratories Suction Pump System	Boehringer Laboratories	2006	5
K131099	AG Mass	Hospitech Respiration, Ltd.	2013	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?

Its one ancestor has no recall.
Of its descendants, K080275 (Iasis Medical, Inc., 2008) has gone furthest, with 37 descendants of its own.
8 other devices also cite its predicate K983552.

How does its category compare?

All JCX devices

JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JCX

2in 2025

2007high 5 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JCX

30in 2019

2007high 144 (2013) · low 30 (2019)2026

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

Recalls per year · JCX

1in 2020

2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JCX

45in 2025

2007high 227 (2021) · low 7 (2010)2025

MAUDE reports naming product code JCX, 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	48
2008	4	43	3	57
2009	1	—	0	34
2010	1	—	0	7
2011	2	—	2	9
2012	2	—	0	18
2013	5	144	2	12
2014	4	106	0	68
2015	0	—	0	118
2016	2	—	0	119
2017	2	—	1	102
2018	2	—	0	170
2019	3	30	0	132
2020	0	—	1	89
2021	0	—	0	227
2022	1	—	0	215
2023	1	—	0	187
2024	1	—	0	103
2025	2	—	0	45
2026	1	—	1	—

What is it indicated for?

The Boehringer Laboratories Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060277 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060277: Boehringer Laboratories Suction Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060277

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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