510(k) · Cleared
ClearedBard William Harvey HF-6000 Membrane Oxygenator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Oct 30, 1996 as substantially equivalent to K920889 (Medtronic Vascular, 1992) and 1 other predicate after a 373-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Oct 30, 1996
- Review
- 373 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903436 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK903436 Sarns Membrane Oxgenator Part Number 94433M Health Care, Sarns · 1990
- This deviceK954850 Bard William Harvey HF-6000 Membrane OxygenatorC.R. Bard, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903436 | Sarns Membrane Oxgenator Part Number 9443 | 3M Health Care, Sarns | 1990 | — |
| 0 (this device) | K954850 | Bard William Harvey HF-6000 Membrane Oxygenator | C.R. Bard, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
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 DTZ? 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 DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K920889 | Minimax (R)/Maxima (R) Hollow Fiber OxygenatorsSummary page 1…iopulmonary bypass procedure for a period of up to six (6) hours. The predicate devices for this 510(k) Notification are: 1) Medtronic MAXTMA® Hollow Fiber Oxygenator (K920889) 2) Sarns™ Turbo Membrane Oxygenator (K903436) Based on a review of FOI-released copies of 510(k) #K920889 and the 510(k) summar… | 1992 |
| * | K903436 | Sarns Membrane Oxgenator Part Number 9443Summary page 1…p to six (6) hours. The predicate devices for this 510(k) Notification are: 1) Medtronic MAXTMA® Hollow Fiber Oxygenator (K920889) 2) Sarns™ Turbo Membrane Oxygenator (K903436) Based on a review of FOI-released copies of 510(k) #K920889 and the 510(k) summary for 510(k) #K941653 (which makes reference t… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, 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 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
The HF-6000 Oxygenator provides the gas exchange and temperature regulating
capacity required to support a patient undergoing a cardiopulmonary bypass
procedure for a period of up to six (6) hours.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K954850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954850: Bard William Harvey HF-6000 Membrane Oxygenator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954850
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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