510(k) · Cleared
ClearedCD-Chex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · GGL Control, White-Cell
Cleared on May 31, 1992 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 31, 1992
- Review
- 90 days
- Class
- Class II
- Product code
- GGL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK920997 CD-ChexStreck Laboratories, Inc. · 1992
- Descendant · cites it directly · 3 of its ownK960894 CD-Chex + RBCStreck Laboratories, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK961610 R & D Systems' Whole Blood Flow Control, (R & D - WBFC)R&D Systems, Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK051633 CD-Chex Plus BCStreck · 2005
- Descendant · 2 generations on · 1 of its ownK982231 StatusflowR&D Systems, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK150815 BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto…Becton, Dickinson and Company · 2015 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K960894CD-Chex + RBCStreck Laboratories, Inc. · 1996 · cites it directly3descendants
- K961610R & D Systems' Whole Blood Flow Control, (R & D - WBFC)R&D Systems, Inc. · 1996 · cites it directly2descendants
- K051633CD-Chex Plus BCStreck · 2005 · 2 generations on1descendant
- K982231StatusflowR&D Systems, Inc. · 1998 · 2 generations on1descendant
- K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitBecton, Dickinson and Company · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920997 | CD-Chex | Streck Laboratories, Inc. | 1992 | — |
| +1 | K960894 | CD-Chex + RBC | Streck Laboratories, Inc. | 1996 | — |
| +1 | K961610 | R & D Systems' Whole Blood Flow Control, (R & D - WBFC) | R&D Systems, Inc. | 1996 | — |
| +2 | K051633 | CD-Chex Plus BC | Streck | 2005 | — |
| +2 | K982231 | Statusflow | R&D Systems, Inc. | 1998 | 1 |
| +2 | K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb… | Becton, Dickinson and Company | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 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 GGL? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K960894 (Streck Laboratories, Inc., 1996) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GGL devicesGGL Control, White-Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGL
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GGL
Too few GGL 510(k)s in any year since 2007 to give a median.
Recalls per year · GGL
No recall names GGL since 2007.
Adverse event reports per year · GGL
1in 2023
MAUDE reports naming product code GGL, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K920997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920997: CD-Chex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920997
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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