510(k) · Cleared
ClearedModel TP Thermistor Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jun 30, 1983 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 30, 1983
- Review
- 49 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK831528 Model TP Thermistor ProbeScimed Life Systems, Inc. · 1983
- Descendant · cites it directly · 4 of its ownK100645 Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or…Medtronic, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK141233 Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface…Medtronic, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK172984 Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie…Medtronic, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK160091 Temperature Probe, Affinity Temperature ProbeMedtronic, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK123448 Affinity Flexible Luer Lock Adapter with Balance Biosurface…Medtronic, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K100645Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance BiosurfaceMedtronic, Inc. · 2012 · cites it directly4descendants
- K141233Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceMedtronic, Inc. · 2014 · 2 generations on1descendant
- K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc. · 2017 · 2 generations on0descendants
- K160091Temperature Probe, Affinity Temperature ProbeMedtronic, Inc. · 2016 · cites it directly0descendants
- K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…Medtronic, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K831528 | Model TP Thermistor Probe | Scimed Life Systems, Inc. | 1983 | — |
| +1 | K100645 | Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance… | Medtronic, Inc. | 2012 | — |
| +2 | K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance… | Medtronic, Inc. | 2014 | — |
| +2 | K172984 | Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator… | Medtronic, Inc. | 2017 | — |
| +1 | K160091 | Temperature Probe, Affinity Temperature Probe | Medtronic, Inc. | 2016 | — |
| +2 | K123448 | Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible… | Medtronic, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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.
Planning a device in DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (5)
2 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, K100645 (Medtronic, Inc., 2012) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K831528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K831528: Model TP Thermistor Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K831528
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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