510(k) · Cleared
ClearedCprcoach Voice Prompter & CPR Prompter Rescue Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Feb 21, 1986 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Feb 21, 1986
- Review
- 7 days
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK860555 Cprcoach Voice Prompter & CPR Prompter Rescue AidAuralogic · 1986
- Descendant · cites it directly · 2 of its ownK081330 Carevent Par (Public Access Resuscitator)O-Two Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK141595 O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK221634 Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A · 2023
Class I recalls in this family
- K141595 O-Two E700,O-Two E600,O-Two E5002 generations on · 2015
Most influential descendants
Showing 3 of 3 · See all- K081330Carevent Par (Public Access Resuscitator)O-Two Medical Technologies, Inc. · 2009 · cites it directly2descendants
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 2 generations on1descendant
- K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860555 | Cprcoach Voice Prompter & CPR Prompter Rescue Aid | Auralogic | 1986 | — |
| +1 | K081330 | Carevent Par (Public Access Resuscitator) | O-Two Medical Technologies, Inc. | 2009 | — |
| +2 | K141595 | O-Two E700,O-Two E600,O-Two E500 | O-Two Medical Technologies, Inc. | 2015 | Class I |
| +3 | K221634 | Oxymag - Transport and Emergency Ventilator | Magnamed Tecnologia Medica S/A | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2015 | 1 | 1 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081330 | Carevent Par (Public Access Resuscitator) | 2009 | 2 |
Has anything in its family been recalled? (1 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.
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K081330 (O-Two Medical Technologies, Inc., 2009) has gone furthest, with 2 descendants of its own.
https://510kreport.com/device/K860555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K860555: Cprcoach Voice Prompter & CPR Prompter Rescue Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860555
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026