FDA product code · Hematology
GKZCounter, Differential Cell
Product code GKZ covers Counter, Differential Cell, a Class II device regulated under 21 CFR 864.5220. FDA has cleared 380 devices in this code, 3 of them in the last 12 months. Median review time across the 380 most recent decisions is 105 days. openFDA lists 244 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 864.5220
- Review panel
- Hematology
- Clearances
- 380
What is happening in GKZ right now?
GKZ (Counter, Differential Cell) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0489-2026, Z-2572-2025, Z-2573-2025, Z-2574-2025, Z-2575-2025). 1 first-time filer in the last 12 months, Truvian Sciences, Inc (K251249). The code is crowded, scoring 68 of 100 — 86 companies hold a clearance here and 3 arrived in the last 12 months (GKZ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0489-2026, Z-2572-2025, Z-2573-2025, Z-2574-2025, Z-2575-2025 |
| New entrant | Worth knowing | K251249 |
| Crowding | Context | GKZ:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in GKZ?
FDA has cleared 380 devices under product code GKZ since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology Analyzers | Sysmex America, Inc. | |
| K243348 | Athelas Home | Athelas, Inc. | |
| K251249 | Tru Hematology Test | Truvian Sciences, Inc. | |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology Analyzer | Sysmex America, Inc. | |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology Analyzer | Sysmex America, Inc. | |
| K243283 | Alinity h-series System | Abbott Laboratories | |
| K240402 | Cito CBC System | Cytochip, Inc. | |
| K240252 | UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System | Beckman Coulter, Inc. | |
| K232946 | Yumizen H2500 | HORIBA ABX SAS | |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies |
How long does FDA review take for GKZ?
The median FDA review time for GKZ is 105 days, measured across the 380 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in GKZ?
openFDA lists 244 recall records against product code GKZ. A recall record covers one firm's corrective action and may span many device lots.
Z-0489-2026Open, ClassifiedAbbott Laboratories, Inc.
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Z-2572-2025Open, ClassifiedBeckman Coulter, Inc.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Z-2573-2025Open, ClassifiedBeckman Coulter, Inc.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Z-2574-2025Open, ClassifiedBeckman Coulter, Inc.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Z-2575-2025Open, ClassifiedBeckman Coulter, Inc.
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
Showing the 5 most recently initiated of 244. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for GKZ?
MAUDE holds 316 adverse-event reports naming product code GKZ, 43 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in GKZ unusual?
Every month with enough history behind it falls inside GKZ's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 14 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 4 | 0–15 | Within expected (0–15) | |
| 3 | 0–11 | Within expected (0–11) | |
| 10 | 0–11 | Within expected (0–11) | |
| 8 | 2–12 | Within expected (2–12) | |
| 8 | 2–11 | Within expected (2–11) | |
| 7 | 3–11 | Within expected (3–11) | |
| 5 | 5–18 | Below expected (5–18) | |
| 8 | 2–12 | Within expected (2–12) | |
| 7 | 3–13 | Within expected (3–13) | |
| 3 | 2–13 | Within expected (2–13) | |
| 3 | 0–11 | Within expected (0–11) | |
| 9 | 0–12 | Within expected (0–12) | |
| 3 | 0–15 | Within expected (0–15) | |
| 7 | 0–12 | Within expected (0–12) | |
| 5 | 0–13 | Within expected (0–13) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in GKZ.
Who has entered GKZ in the last year?
One company filed in GKZ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Truvian Sciences, Inc. | K251249 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in GKZ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in GKZ?
Across the 380 most recent decisions, these applicants filed most often in GKZ.
| Applicant | Recent clearances |
|---|---|
| Beckman Coulter, Inc. | 25 |
| Abbott Laboratories | 24 |
| Coulter Corp. | 23 |
| Sysmex America, Inc. | 22 |
| Becton Dickinson Immunocytometry Systems | 21 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in GKZ files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Beckman Coulter, Inc. | 28 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch GKZ
Get an email the morning anything changes in GKZ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.