510(k) · Cleared
ClearedD100 Kids; D101 Kids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Nov 16, 2023 as substantially equivalent to K072091 (Sorin Group Italia S.R.L., 2007) after a 163-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Nov 16, 2023
- Review
- 163 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K991737 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK991737 Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)…Dideco S.P.A. · 2000 · Recalled
- 2 generations backK061031 D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator…Sorin Group Italia S.R.L. · 2006
- 1 generation backK072091 D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated…Sorin Group Italia S.R.L. · 2007
- This deviceK231652 D100 Kids; D101 KidsSorin Group Italia S.R.L. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991737 | Lilliput Phospholypidic Inert Surface in Oxygenation (PH.I.S.I.O.)… | Dideco S.P.A. | 2000 | 1 |
| −2 | K061031 | D 100 L001 PH.I.S.I.O.: Newborn Hollow Fiber Membrane Oxygenator with… | Sorin Group Italia S.R.L. | 2006 | — |
| −1 | K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell… | Sorin Group Italia S.R.L. | 2007 | — |
| 0 (this device) | K231652 | D100 Kids; D101 Kids | Sorin Group Italia S.R.L. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K060103 | FDA’s K060103 is Albert Browne LTD. Verify Steam Value Indicators Our reading of the summary gave K060103, FDA’s number for Albert Browne LTD. Verify Steam Value Indicators (Albert Browne, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “D100 KIDS”. Kept off the family tree. Summary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K0601031 I D100 KIDS I DTZ IK072091… | 2006 |
| * | K072091 | D101 Kids Infant Hollow Fiber Membrane Oxygenator with Integrated Hardshell…Summary page 4…Product Code I K0601031 I D100 KIDS I DTZ IK072091 I D101 KIDS I DTZ Device Desc… | 2007 |
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?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 4 other devices also cite its predicate K072091.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 D100 devices are indicated for use for neonatal patients undergoing surgical procedures requiring cardiopulmonary bypass. The oxygenator is intended to be used for six hours or less.
The D101 devices are indicated for use for infant patients undergoing surgical procedures requiring cardiopulmonary bypass The oxygenator is intended to be used for six hours or less
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231652 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231652: D100 Kids; D101 Kids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231652
Report an extraction error
Are you the manufacturer?
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