510(k) · Cleared

Cleared

Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S

K061133510(k) TraditionalCleared Jul 11, 200678-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

Novaspine, LLC · BTA Pump, Portable, Aspiration (Manual Or Powered)

Cleared on Jul 11, 2006 as substantially equivalent to K971749 (Precision Medical, Inc., 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1998. 18 later devices descend from it.

Decided: Jul 11, 2006
Review: 78 days
Class: Class II
Product code: BTA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K971749 (1998). 2 ancestors in all. 18 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK971749 Easygo AspiratorPrecision Medical, Inc. · 1998 · Recalled
This deviceK061133 Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SNovaspine, LLC · 2006
Descendant · cites it directly · 16 of its ownK062456 Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006
Descendant · 2 generations on · 15 of its ownK112458 Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy…Medica-Rents Co., Ltd. · 2012
Descendant · 2 generations on · 4 of its ownK113291 Simex Negative Pressure Wound Therapy Powered Suction Pumps Series…Simex Medizintechnik GmbH · 2012
Descendant · 3 generations on · 3 of its ownK162159 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017
Descendant · cites it directly · 3 of its ownK141255 Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH · 2014

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2006high 3 (2012) · low 0 (2007)2026

Most influential descendants

Showing 5 of 18 · See all

K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC · 2006 · cites it directly16descendants
K112458Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy SystemMedica-Rents Co., Ltd. · 2012 · 2 generations on15descendants
K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH · 2012 · 2 generations on4descendants
K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017 · 3 generations on3descendants
K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH · 2014 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971749	Easygo Aspirator	Precision Medical, Inc.	1998	2
0 (this device)	K061133	Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S	Novaspine, LLC	2006	—
+1	K062456	Novaspine Powered Suction Pump Pro-1	Novaspine, LLC	2006	—
+2	K112458	Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy System	Medica-Rents Co., Ltd.	2012	—
+2	K113291	Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200…	Simex Medizintechnik GmbH	2012	—
+3	K162159	VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing	Vr Medical Technologies, LLC	2017	—
+1	K141255	Simex Subglottic Aspiration System	Simex Medizintechnik GmbH	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2012	3	0
2014	2	0
2016	2	0
2017	1	0
2018	3	0
2019	2	0
2021	1	0
2022	2	0
2024	1	0

FIG. 1 — Lineage of K061133, 1998–2024Source: 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
*	K971749	Easygo Aspirator Summary page 1 …ed) Substantial Equivalency Code: BTA Precision Medical, Inc. "Easy Go", K 971749 Medela, Inc. "Vario", K 983552 D…	Precision Medical, Inc.	1998	2
*	K983552	Basic, Median, Dominant, and Vario Summary page 1 …, Inc. "Easy Go", K 971749 Medela, Inc. "Vario", K 983552 Device Description: The SIMEX Suction Pump is a lightweight portable or stationary suction/aspirator pump for me…	Medela, Inc.	1999	—

Also cleared against K971749: 2 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K062456	Novaspine Powered Suction Pump Pro-1	Novaspine, LLC	2006	16
K141255	Simex Subglottic Aspiration System	Simex Medizintechnik GmbH	2014	3
K133196	Impact Model 323 Aspirator	Impact Instrumentation, Inc.	2014	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, K062456 (Novaspine, LLC, 2006) has gone furthest, with 16 descendants of its own.
2 other devices also cite its predicate K971749.

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 SIMEX Portable Suction/Aspirator/Vacuum system is indicated and used for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at patient's bedside.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061133 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061133: Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061133

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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