510(k) · Cleared

Cleared

Advia 120 Hematology System Complete Blood Count (CBC) Method

K022668510(k) TraditionalCleared Oct 15, 200264-day reviewClass II21 CFR 864.5220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bayer Diagnostics Corp. · GKZ Counter, Differential Cell

Cleared on Oct 15, 2002 as substantially equivalent to K971998 (Bayer Corp., 1997) after a 64-day review. Its family tree reaches back 1 generation to 1997.

Decided: Oct 15, 2002
Review: 64 days
Class: Class II
Product code: GKZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971998 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK971998 Advia 120 Hematology System, in Vitro Diagnostic SystemBayer Corp. · 1997 · Recalled
This deviceK022668 Advia 120 Hematology System Complete Blood Count (CBC) MethodBayer Diagnostics Corp. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971998	Advia 120 Hematology System, in Vitro Diagnostic System	Bayer Corp.	1997	2
0 (this device)	K022668	Advia 120 Hematology System Complete Blood Count (CBC) Method	Bayer Diagnostics Corp.	2002	—

FIG. 1 — Lineage of K022668, 1997–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K971998	Advia 120 Hematology System, in Vitro Diagnostic System Summary page 1 …rmation provides data supporting a substantially equivalent determination between the ADVIA 120 cellular Hgb method (Hgbcell)and the ADVIA 120 HgbTotal predicate method (K971998). Intended Use The ADVIA 120 Hgbcellparameter is intended to provide an in vitro diagnostic, quantitative measurement of hemoglo…	Bayer Corp.	1997	2

Also cleared against K971998: 2 other devices →

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?

Its one ancestor has a recall.
2 other devices also cite its predicate K971998.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKZ

4in 2025

2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007high 638 (2022) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GKZ

1in 2025

2007high 37 (2007) · low 0 (2014)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · GKZ

77in 2025

2007high 3,338 (2016) · low 77 (2025)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?

The ADVLATM120 Hematology System Complete Blood Count (CBC) method is intended to

quantitatively measure the following hematological parameters:

White Blood Cell count (WBC)

Red Blood Cell count (RBC)

Hematocrit (HCT)

Mean Corpuscular Volume (MCV)

Mean Corpuscular Hemoglobin (MCH)

Mean Corpuscular Hemoglobin Concentration (MCHC)

Corpuscular Hemoglobin Concentration Mean (CHCM)

Cellular Hemoglobin Content (CH)

Red Cell Volume Distribution Width (RDW)

Hemoglobin Concentration Distribution Width (HDW)

Platelet Count (PLT)

Mean Platelet Volume (MPV)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022668 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022668: Advia 120 Hematology System Complete Blood Count (CBC) Method.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022668

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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