510(k) · Cleared
ClearedAspire Mechanical Aspirator G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Control Medical Technology · FMF Syringe, Piston
Cleared on May 29, 2020 as substantially equivalent to K072299 (Pinyons Medical Technology, Inc., 2007) and 2 other predicates after an 80-day review. Its family tree reaches back 9 generations to 1990. 3 of the 77 devices in its family, counting itself, have a Class I recall.
- Decided
- May 29, 2020
- Review
- 80 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K904788 (1990). 76 ancestors in all, the oldest K832023 (1983). No later device cites it as a predicate yet. 3 of the 77 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 5 generations between
- 3 generations backK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
- 2 generations backK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- 1 generation backK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- This deviceK200629 Aspire Mechanical Aspirator GControl Medical Technology · 2020
Show all 9 generations
- Root · 9 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 8 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 7 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 6 generations backK031485 Rinspiration SystemKerberos Proximal Solutions · 2003
- 5 generations backK041291 Rinspiration SystemKerberos Proximal Solutions, Inc. · 2004
- 4 generations backK050130 Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc. · 2005
- 3 generations backK062275 Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc. · 2006
- 2 generations backK080901 Lbi Embolectomy SystemLumen Biomedical, Inc. · 2008
- 1 generation backK113757 Aspire Max Aspiration CatheterControl Medical Technology, LLC · 2012
- This deviceK200629 Aspire Mechanical Aspirator GControl Medical Technology · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −8 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −7 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −6 | K031485 | Rinspiration System | Kerberos Proximal Solutions | 2003 | — |
| −5 | K041291 | Rinspiration System | Kerberos Proximal Solutions, Inc. | 2004 | — |
| −4 | K050130 | Kerberos Proximal Solutions Rispiration System | Kerberos Proximal Solutions, Inc. | 2005 | — |
| −3 | K062275 | Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 | Kerberos Proximal Solutions, Inc. | 2006 | — |
| −2 | K080901 | Lbi Embolectomy System | Lumen Biomedical, Inc. | 2008 | — |
| −1 | K113757 | Aspire Max Aspiration Catheter | Control Medical Technology, LLC | 2012 | — |
| 0 (this device) | K200629 | Aspire Mechanical Aspirator G | Control Medical Technology | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 1 |
| 1998 | 8 | 1 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 1 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
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.
3 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K072299 | Powrsyringe AspiratorSummary page 4…FMF Regulation: Class II, 21 CFR 880.5860 3. Predicate Device Trade Names: Aspire Mechanical Aspirator K072299 (“Aspire Aspirator” and/or “Predicate”) Common Name: Syrin… | 2007 |
| * | K113757 | Aspire Max Aspiration CatheterSummary page 4…SUBJECT DEVICE Aspire Aspirator Aspire Aspirator G K072299. Also K113757 and K131998 Page 1 of 5… | 2012 |
| * | K131998 | Aspire RX-LP6 Aspiration CatheterSummary page 4…Aspire Aspirator Aspire Aspirator G K072299. Also K113757 and K131998 Page 1 of 5 Section 5 51… | 2013 |
| † | K072345 | Powrsyringe Monitor | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K022145Over the Wire Embolectomy Catheter, Model 2302LeMaitre Vascular, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K973465Latis Graft Cleaning CatheterApplied Medical Resources · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970762Dual Lumen Embolectomy CatheterApplied Medical Resources · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 14 of the 76 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Aspire Aspirator G is a piston syringe to inject fluids into, or aspirate fluids from, the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200629: Aspire Mechanical Aspirator G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200629
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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