510(k) · Cleared
Cleared3M Cdi Quick-Cells with Heparin Treatment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Healthcare · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on May 15, 1998 as substantially equivalent to K890113 (Cardiovascular Devices, Inc., 1989) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- May 15, 1998
- Review
- 79 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K890113 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK890113 The Cdi (R) System 400Cardiovascular Devices, Inc. · 1989
- This deviceK980732 3M Cdi Quick-Cells with Heparin Treatment3M Healthcare · 1998
- Descendant · cites it directly · 0 of its ownK140042 1.5MM Hydro Expandable Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K1400421.5MM Hydro Expandable Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890113 | The Cdi (R) System 400 | Cardiovascular Devices, Inc. | 1989 | — |
| 0 (this device) | K980732 | 3M Cdi Quick-Cells with Heparin Treatment | 3M Healthcare | 1998 | — |
| +1 | K140042 | 1.5MM Hydro Expandable Lemaitre Valvulotome | LeMaitre Vascular, Inc. | 2014 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 DRY? 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 DRY device
- #1 K234065 CDI OneView Monitoring Systemscore 5.5 · 2 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 |
|---|---|---|---|
| * | K890113 | The Cdi (R) System 400Summary page 1…blood gas monitor and cardiopulmonary bypass in line blood gas sensor (21 CFR 870.4330) Predicate Devices: Product 510(k) Number Clearance Date CDI 400 Extracorporeal K890113 5/23/89 Hematocrit/Oxygen Saturation Monitoring System CDI 100 Extracorporeal K902654 11/5/90 Hematocrit/Oxygen Saturation Monit… | 1989 |
| * | K902654 | Cdi (TM) System 100 Monitoring SystemSummary page 1…Predicate Devices: Product 510(k) Number Clearance Date CDI 400 Extracorporeal K890113 5/23/89 Hematocrit/Oxygen Saturation Monitoring System CDI 100 Extracorporeal K902654 11/5/90 Hematocrit/Oxygen Saturation Monitoring System Device Description: The 3M CDI H/S QUIK-CELLS with Heparin Treatment are… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140042 | 1.5MM Hydro Expandable Lemaitre Valvulotome | 2014 | 0 |
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?
How does its category compare?
All DRY devicesDRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRY
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRY
134in 2025
MAUDE reports naming product code DRY, 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 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 0 | — | 6 | 1,070 |
| 2011 | 2 | — | 14 | 2,268 |
| 2012 | 1 | — | 5 | 167 |
| 2013 | 0 | — | 0 | 157 |
| 2014 | 2 | — | 0 | 156 |
| 2015 | 0 | — | 1 | 231 |
| 2016 | 0 | — | 0 | 240 |
| 2017 | 1 | — | 0 | 61 |
| 2018 | 3 | 88 | 0 | 165 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 1 | — | 1 | 35 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 0 | — | 0 | 37 |
| 2023 | 0 | — | 0 | 41 |
| 2024 | 1 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 134 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These cells are to be used with the CDI System 400 Extracorporeal Blood Gas Monitoring System, which is intended for use during cardiopulmonary bypass procedures when contiuous monitoring of blood gases is desired.
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/K980732 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980732: 3M Cdi Quick-Cells with Heparin Treatment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980732
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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