510(k) · Cleared
Recalled · Class II · 2018Care-E-Vac 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohio Medical Corporation · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Sep 28, 2006 as substantially equivalent to K926566 (Aeros Instruments, Inc., 1993) after a 23-day review. Its family tree reaches back 1 generation to 1993. It has been recalled 2 times.
- Decided
- Sep 28, 2006
- Review
- 23 days
- Class
- Class II
- Product code
- BTA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926566 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926566 Care-E-VacAeros Instruments, Inc. · 1993
- This deviceK062610 Care-E-Vac 3Ohio Medical Corporation · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926566 | Care-E-Vac | Aeros Instruments, Inc. | 1993 | — |
| 0 (this device) | K062610 | Care-E-Vac 3 | Ohio Medical Corporation | 2006 | — |
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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K926566 | Care-E-VacSummary page 1…CFR Reference: 21CFR878.4780 Classification Name: Pump, Portable, Aspiration Product Code: BTA Predicate Device: K926566 - Care-E-Vac II Device Description: The device uses conventional technology to provide medical suction.… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2018 | Class II | Z-2995-2018 | Nonconforming Material/Component | The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power. |
| Nov 8, 2010 | Not classified | Z-0833-2011 | Device Design | The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All BTA devicesBTA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 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 device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the care-e-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062610 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062610: Care-E-Vac 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062610
Report an extraction error
Are you the manufacturer?
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