510(k) · Cleared
ClearedElectromedics Blood Heat Exchanger
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electromedics, Inc. · DTR Heat-Exchanger, Cardiopulmonary Bypass
Cleared on Dec 3, 1993 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 3, 1993
- Review
- 87 days
- Class
- Class II
- Product code
- DTR
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK934355 Electromedics Blood Heat ExchangerElectromedics, Inc. · 1993
- Descendant · cites it directly · 3 of its ownK960755 Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996
- Descendant · 2 generations on · 0 of its ownK991137 Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000
- Descendant · 2 generations on · 0 of its ownK973237 CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK973475 Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx…Medtronic Vascular · 1997
Most influential descendants
Showing 4 of 4 · See all- K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996 · cites it directly3descendants
- K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000 · 2 generations on0descendants
- K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998 · 2 generations on0descendants
- K973475Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr…Medtronic Vascular · 1997 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934355 | Electromedics Blood Heat Exchanger | Electromedics, Inc. | 1993 | — |
| +1 | K960755 | Cardiotherm Blood Cardioplegia Systems | Medtronic Cardiac Surgery, Medtronic, Inc. | 1996 | — |
| +2 | K991137 | Enguard PHX Cardioplegia Heat Exchanger | Minntech Corp. | 2000 | — |
| +2 | K973237 | CSS-Cardioplegia Safety System | Medtronic Bio-Medicus, Inc. | 1998 | — |
| +2 | K973475 | Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and… | Medtronic Vascular | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 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 DTR? 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 DTR device
- #1 K252541 Quantum PureFlow Standard Heat Exchanger…score 13.4 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960755 | Cardiotherm Blood Cardioplegia Systems | 1996 | 3 |
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, K960755 (Medtronic Cardiac Surgery, Medtronic, Inc., 1996) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DTR devicesDTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTR
Too few DTR 510(k)s in any year since 2007 to give a median.
Recalls per year · DTR
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTR
44in 2025
MAUDE reports naming product code DTR, 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 | 2 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 24 | 43 |
| 2011 | 0 | — | 3 | 67 |
| 2012 | 0 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 27 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 0 | — | 1 | 96 |
| 2016 | 0 | — | 0 | 60 |
| 2017 | 2 | — | 0 | 69 |
| 2018 | 1 | — | 0 | 75 |
| 2019 | 0 | — | 0 | 35 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 2 | — | 0 | 23 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 2 | — | 0 | 44 |
| 2026 | 1 | — | 2 | — |
https://510kreport.com/device/K934355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K934355: Electromedics Blood Heat Exchanger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934355
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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