510(k) · Cleared
ClearedOrtho Immunocount Flow Cytometry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Diagnostic Systems, Inc. · GKZ Counter, Differential Cell
Cleared on Apr 30, 1996 as substantially equivalent to K896873 (Coulter Corp., 1990) and 1 other predicate after a 211-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Apr 30, 1996
- Review
- 211 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K895127 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK895127 ARGOSAbx, Inc. · 1989
- This deviceK954570 Ortho Immunocount Flow Cytometry SystemOrtho Diagnostic Systems, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895127 | ARGOS | Abx, Inc. | 1989 | — |
| 0 (this device) | K954570 | Ortho Immunocount Flow Cytometry System | Ortho Diagnostic Systems, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 GKZ? 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 GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 | K93292 | Simultest reagents Number could not be read Summary page 1…995 ( v as43570 APR 30 Joos CONTACT: Joanne Harris Tel.: (908) 218-8404 FAX.: (908) 218-8168 PREDICATE: FACScan™ Flow Cytometer Simulset Software Simultest™ reagents K93292 Simultest Control 1gG,/1gG-, (I8G: FITC/IgG2PE) Simultest LeucoGATE™ (CD45/CD14[Anti-HLe 1/Leu™M3}) Simultest CD3/CD4 (Leu-4/3… | |
| * | K896873 | Coulter JT3Summary page 1…eu-4/3a) Simultest CD3/CD8 (Leu-4/Leu-22a) Simultest CD3/CD16+CD56 (Leu-4/11c+19) Simultest T and B Cell Test CD3/CD19 (Leud4/Leul2) Hematology Analyzers Coulter T 540 K896873 Coulter JT2 K874383 AGROS . K895127 Ortho Diagnostic Systems Inc. ORTHO™ ImmunoCount Flow Cytometry System Page 472 === Page 2… | 1990 |
| Kept off the family tree | K874383 | FDA’s K874383 is Mentor Plus (Condom) Our OCR of the scanned summary read K874383, FDA’s number for Mentor Plus (Condom) (Arcon Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Coulter JT2”. Kept off the family tree. Summary page 1…D3/CD8 (Leu-4/Leu-22a) Simultest CD3/CD16+CD56 (Leu-4/11c+19) Simultest T and B Cell Test CD3/CD19 (Leud4/Leul2) Hematology Analyzers Coulter T 540 K896873 Coulter JT2 K874383 AGROS . K895127 Ortho Diagnostic Systems Inc. ORTHO™ ImmunoCount Flow Cytometry System Page 472 DEVICE DESCRIPT… | 1988 |
| * | K895127 | ARGOSSummary page 1…u-22a) Simultest CD3/CD16+CD56 (Leu-4/11c+19) Simultest T and B Cell Test CD3/CD19 (Leud4/Leul2) Hematology Analyzers Coulter T 540 K896873 Coulter JT2 K874383 AGROS . K895127 Ortho Diagnostic Systems Inc. ORTHO™ ImmunoCount Flow Cytometry System Page 472 DEVICE DESCRIPTION: ORTHO Immu… | 1989 |
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.
- 1 other device also cites its predicate K896873.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
ORTHO ImmunoCount Flow Cytometry System is intended to be used for lymphocyte immunophenotyping. Results may be reported as either percent positive cells, or as absolute counts of lymphocytes and lymphocyte subsets.
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/K954570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954570: Ortho Immunocount Flow Cytometry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954570
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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