510(k) Report

510(k) · Cleared

Cleared

Calibrite Percp-CY5.5 Beads and Facscomp Software

K000897510(k) TraditionalCleared May 5, 200045-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

Bd Biosciences · GKZ Counter, Differential Cell

Cleared on May 5, 2000 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
May 5, 2000
Review
45 days
Class
Class II
Product code
GKZ
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK000897 Calibrite Percp-CY5.5 Beads and Facscomp SoftwareBd Biosciences · 2000
  2. Descendant · cites it directly · 2 of its ownK040026 BD Facs 7-Color Setup BeadsBecton Dickinson Immunocytometry Systems · 2004 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK170974 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company · 2017 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5…Becton, Dickinson and Company · 2020 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K040026BD Facs 7-Color Setup BeadsBecton Dickinson Immunocytometry Systems · 2004 · cites it directly2descendants
  • K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Becton, Dickinson and Company · 2017 · 2 generations on1descendant
  • K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…Becton, Dickinson and Company · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000897Calibrite Percp-CY5.5 Beads and Facscomp SoftwareBd Biosciences2000—
+1K040026BD Facs 7-Color Setup BeadsBecton Dickinson Immunocytometry Systems20043
+2K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company201717
+3K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical…Becton, Dickinson and Company20205

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201710
202010
FIG. 1 — Lineage of K000897, 2000–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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. #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040026BD Facs 7-Color Setup BeadsBecton Dickinson Immunocytometry Systems20042

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, K040026 (Becton Dickinson Immunocytometry Systems, 2004) has gone furthest, with 2 descendants of its own.

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

2007: 62008: 62009: 62010: 42011: 32012: 32013: 12014: 32015: 32016: 32017: 42018: 32019: 52020: 12022: 32023: 42024: 32025: 42026 (partial year): 4
2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007: 117 days median2008: 99 days median2009: 147 days median2010: 290 days median2011: 315 days median2012: 408 days median2014: 165 days median2015: 273 days median2016: 198 days median2017: 280 days median2018: 270 days median2019: 210 days median2022: 638 days median2023: 329 days median2024: 157 days median2025: 108 days median2026 (partial year): 254 days median
2007high 638 (2022) · low 99 (2008)2026

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

Recalls per year · GKZ

1in 2025

2007: 372008: 52009: 132010: 272011: 282012: 72013: 62015: 32016: 32017: 32018: 2, 2 Class I2019: 22020: 12022: 42023: 12025: 1
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

2007: 2682008: 9252009: 5592010: 8962011: 2,9052012: 2,9592013: 3,0702014: 3,1122015: 1,9722016: 3,3382017: 2292018: 4972019: 9082020: 3422021: 3912022: 1982023: 1552024: 1152025: 77
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611737268
20086995925
2009614713559
2010429027896
20113315282,905
2012340872,959
20131—63,070
2014316503,112
2015327331,972
2016319833,338
201742803229
201832702 (2)497
201952102908
20201—1342
20210—0391
202236384198
202343291155
202431570115
20254108177
202642540—

More from Bd Biosciences

11 FDA decisions under this applicant name. See the company

  • K260215BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3]…Bd Biosciences · 2026
  • K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3…Bd Biosciences · 2015
  • K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 20093 recalls
  • K081213BD Facscount CD4 Reagents with Model 339010Bd Biosciences · 20082 recalls
  • K071143BD Tritest CD3/CD4/CD45, Model 340383Bd Biosciences · 20071 recall

Recent decisions in GKZ

The GKZ category page

  • K260781Yumizen H550Horiba Abx Sas · 2026
  • K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc. · 2026
  • K243348Athelas HomeAthelas, Inc. · 2026
  • K251249Tru Hematology TestTruvian Sciences, Inc. · 2026
  • K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025

https://510kreport.com/device/K000897 · printed Nov 5, 2026

Cite this page

510(k) Report. “K000897: Calibrite Percp-CY5.5 Beads and Facscomp Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000897

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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