510(k) · Cleared
ClearedPaceart CPTS-86/12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paceart, Inc. · KRE Analyzer, Pacemaker Generator Function, Indirect
Cleared on Apr 14, 1992 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.
- Decided
- Apr 14, 1992
- Review
- 119 days
- Class
- Class II
- Product code
- KRE
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 4 citing it directly.
- This deviceK915632 Paceart CPTS-86/12Paceart, Inc. · 1992
- Descendant · cites it directly · 10 of its ownK020534 Medstar System, Models 533-300Cybernet Medical · 2003 · Recalled
- Descendant · 2 generations on · 8 of its ownK041854 MPM SystemAerotel Medical Systems, Ltd. · 2004
- Descendant · 2 generations on · 7 of its ownK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK982384 MercatorHarley Street Software, Ltd. · 1999
- Descendant · cites it directly · 6 of its ownK982090 Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K020534Medstar System, Models 533-300Cybernet Medical · 2003 · cites it directly10descendants
- K041854MPM SystemAerotel Medical Systems, Ltd. · 2004 · 2 generations on8descendants
- K051544Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005 · 2 generations on7descendants
- K982384MercatorHarley Street Software, Ltd. · 1999 · cites it directly7descendants
- K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915632 | Paceart CPTS-86/12 | Paceart, Inc. | 1992 | — |
| +1 | K020534 | Medstar System, Models 533-300 | Cybernet Medical | 2003 | 4 |
| +2 | K041854 | MPM System | Aerotel Medical Systems, Ltd. | 2004 | — |
| +2 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| +1 | K982384 | Mercator | Harley Street Software, Ltd. | 1999 | — |
| +1 | K982090 | Paceart Home Trak Plus Easi Event Recorder System | Paceart, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
Planning a device in KRE? 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? (27)
See all 274 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K020534 (Cybernet Medical, 2003) has gone furthest, with 10 descendants of its own.
How does its category compare?
All KRE devicesKRE Analyzer, Pacemaker Generator Function, Indirect: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRE
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KRE
Too few KRE 510(k)s in any year since 2007 to give a median.
Recalls per year · KRE
No recall names KRE since 2007.
Adverse event reports per year · KRE
2in 2023
MAUDE reports naming product code KRE, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K915632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915632: Paceart CPTS-86/12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915632
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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