510(k) · Cleared

Cleared

Cell-Dyn 22 Plus Calibrator

K111204510(k) TraditionalCleared Dec 22, 2011237-day reviewClass II21 CFR 864.8150

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

Streck · KRX Calibrator For Cell Indices

Cleared on Dec 22, 2011 as substantially equivalent to K840261 (Streck Laboratories, Inc., 1984) after a 237-day review. Its family tree reaches back 1 generation to 1984.

Decided: Dec 22, 2011
Review: 237 days
Class: Class II
Product code: KRX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K840261 (1984). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK840261 Cal-Chex, a Hematology CalibratorStreck Laboratories, Inc. · 1984 · Recalled
This deviceK111204 Cell-Dyn 22 Plus CalibratorStreck · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K840261	Cal-Chex, a Hematology Calibrator	Streck Laboratories, Inc.	1984	1
0 (this device)	K111204	Cell-Dyn 22 Plus Calibrator	Streck	2011	—

FIG. 1 — Lineage of K111204, 1984–2011Source: 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 KRX? 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

Get a 510(k) Report

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
*	K840261	Cal-Chex, a Hematology Calibrator Summary page 1 …librator Common Name: Assayed Hematology Calibrator Classification Name: Calibrator for Cell Indices (864.8150) Predicate Device: Cal-Chex (K840261) Manufactured by Streck Description: CELL-DYN 22 Plus Calibrator is an in-vitro diagnostic product that may contain any or all o…	Streck Laboratories, Inc.	1984	1

Also cleared against K840261: 1 other device →

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.
1 other device also cites its predicate K840261.

How does its category compare?

All KRX devices

KRX Calibrator For Cell Indices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KRX

1in 2016

2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRX

Too few KRX 510(k)s in any year since 2007 to give a median.

Recalls per year · KRX

No recall names KRX since 2007.

Adverse event reports per year · KRX

1in 2013

2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code KRX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	1	—	0
2012	2	—	1
2013	0	—	1
2014	2	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

CELL-DYN 22 Plus Calibrator is manufactured for calibration of the CELL-DYN Emerald 22 system.

Assayed parameters include:

WBC (109 /L), RBC (1012/L), HOB (g/dL), MCV (fL), PLT (10 1)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111204 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111204: Cell-Dyn 22 Plus Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111204

Report an extraction error

Are you the manufacturer?

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