510(k) · Cleared

Cleared

Medela Dominant 35 C/I Secretion and Surgical Aspirator

K043544510(k) TraditionalCleared Jan 7, 200515-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

Medela AG · BTA Pump, Portable, Aspiration (Manual Or Powered)

Cleared on Jan 7, 2005 as substantially equivalent to K021368 (Medela AG, 2002) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1994. 93 later devices descend from it.

Decided: Jan 7, 2005
Review: 15 days
Class: Class II
Product code: BTA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K933902 (1994). 2 ancestors in all. 93 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK933902 Moblvac IiiAeros Instruments, Inc. · 1994 · Recalled
This deviceK043544 Medela Dominant 35 C/I Secretion and Surgical AspiratorMedela AG · 2005
Descendant · cites it directly · 85 of its ownK061205 Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG · 2006 · Recalled
Descendant · 2 generations on · 75 of its ownK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
Descendant · 3 generations on · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
Descendant · 4 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
Descendant · 4 generations on · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2006high 11 (2016) · low 0 (2007)2026

Most influential descendants

Showing 5 of 93 · See all

K061205Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG · 2006 · cites it directly85descendants
K080357Medela Invia Wound TherapyMedela AG · 2008 · 2 generations on75descendants
K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · 3 generations on56descendants
K111170PICOSmith & Nephew, Inc. · 2011 · 4 generations on26descendants
K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · 4 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933902	Moblvac Iii	Aeros Instruments, Inc.	1994	1
0 (this device)	K043544	Medela Dominant 35 C/I Secretion and Surgical Aspirator	Medela AG	2005	—
+1	K061205	Medela Vario 8/18/CI Secretion & Surgical Aspirator	Medela AG	2006	1
+2	K080357	Medela Invia Wound Therapy	Medela AG	2008	1
+3	K083375	Renasys GO Negative Pressure Wound Therapy	Smith & Nephew, Inc.	2009	2
+4	K111170	PICO	Smith & Nephew, Inc.	2011	—
+4	K112127	Pico Single Use Negative Pressure Wound Therapy System	Smith & Nephew, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	2	0
2009	2	0
2010	1	0
2011	3	0
2012	6	0
2013	2	0
2014	6	0
2015	5	0
2016	11	0
2017	8	0
2018	10	0
2019	8	0
2020	4	0
2021	3	0
2022	9	0
2023	3	0
2024	2	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K043544, 1994–2026Source: 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 BTA? 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 BTA device

#1 K222547 Electric nasal aspiratorscore 20.7 · 6 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
*	K021368	Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057 Summary page 1 …ified Class II, per 21 CFR Section 878.4780). 3 Name of the predicate Device(s) * Medela® Basic 30 & Dominant 50 Suction Pumps, by Medela Inc. K021368 Aeros MobIvac III Aspirator, by Aeros Instruments, Inc. K933902 Applicant: Medela AG, Lae…	Medela AG	2002	—
*	K933902	Moblvac Iii Summary page 1 …te Device(s) * Medela® Basic 30 & Dominant 50 Suction Pumps, by Medela Inc. K021368 Aeros MobIvac III Aspirator, by Aeros Instruments, Inc. K933902 Applicant: Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Contact Person: Bruno Gretler, Tel…	Aeros Instruments, Inc.	1994	1

Also cleared against K021368: 7 other devices →

What descends from it? (93)

See all 93

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

Number	Device	Applicant	Decided	Descendants
K061205	Medela Vario 8/18/CI Secretion & Surgical Aspirator	Medela AG	2006	85
K100624	Invendo C20 Colonoscopy System	Invendo Medical Gbmh	2012	6
K080212	Medela Thopaz, Model 200 0288	Medela AG	2008	5

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, K061205 (Medela AG, 2006) has gone furthest, with 85 descendants of its own.
7 other devices also cite its predicate K021368.

How does its category compare?

All BTA devices

BTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BTA

7so far in 2026, the most since 2007

2007high 7 (2026) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BTA

87in 2025

2007high 265 (2023) · low 45 (2013)2026

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

Recalls per year · BTA

1in 2021

2007high 3 (2008) · low 0 (2009)2026

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

Adverse event reports per year · BTA

13in 2025

2007high 399 (2014) · low 4 (2017)2025

MAUDE reports naming product code BTA, 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	1	—	1	13
2008	3	135	3	5
2009	2	—	0	14
2010	2	—	3	178
2011	1	—	0	62
2012	1	—	0	47
2013	3	45	0	18
2014	3	91	0	399
2015	0	—	0	15
2016	3	149	0	25
2017	1	—	0	4
2018	4	125	0	17
2019	0	—	0	14
2020	1	—	0	10
2021	1	—	1	9
2022	3	58	0	7
2023	4	265	0	8
2024	5	131	0	13
2025	6	87	0	13
2026	7	89	0	—

What is it indicated for?

The Dominant 35 c/i Suction Pump is indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patients bedside.

Generally the Dominant 35 c/i is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal, wound and thoracic drainage (must be used only in combination with a chest drainage unit with a built inflow adjustment valve) in either "constant" or "intermittent" mode.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043544 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043544: Medela Dominant 35 C/I Secretion and Surgical Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043544

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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