510(k) · Cleared
ClearedCBC-4K Hematology Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R&D Systems, Inc. · JPK Mixture, Hematology Quality Control
Cleared on Jan 12, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jan 12, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK003874 CBC-4K Hematology ControlR&D Systems, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK052440 Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corporation · 2005
- Descendant · 2 generations on · 2 of its ownK071496 Icath, SterilesureColorado Catheter Company, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK103043 Colorado Catheter Sterilesure - New Name Perfic CathAdapta Medical, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK161445 PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC…Adapta Medical, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K052440Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corporation · 2005 · cites it directly3descendants
- K071496Icath, SterilesureColorado Catheter Company, Inc. · 2007 · 2 generations on2descendants
- K103043Colorado Catheter Sterilesure - New Name Perfic CathAdapta Medical, Inc. · 2011 · 3 generations on1descendant
- K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc. · 2016 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003874 | CBC-4K Hematology Control | R&D Systems, Inc. | 2001 | — |
| +1 | K052440 | Mentor Self-Cath Hydrogel Intermittent Catheter | Mentor Corporation | 2005 | — |
| +2 | K071496 | Icath, Sterilesure | Colorado Catheter Company, Inc. | 2007 | — |
| +3 | K103043 | Colorado Catheter Sterilesure - New Name Perfic Cath | Adapta Medical, Inc. | 2011 | — |
| +4 | K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | Adapta Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 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 JPK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052440 | Mentor Self-Cath Hydrogel Intermittent Catheter | 2005 | 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, K052440 (Mentor Corporation, 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPK
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JPK
296in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPK
2in 2023
MAUDE reports naming product code JPK, 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 | 5 | 44 | 1 | 14 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 5 | 187 | 0 | 0 |
| 2010 | 4 | 267 | 2 | 5 |
| 2011 | 1 | — | 3 | 56 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 296 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 2 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003874: CBC-4K Hematology Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003874
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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