510(k) · Cleared

Cleared

Document Reflectance II Linearity Test Set

K910440510(k) TraditionalCleared May 10, 199199-day reviewClass I21 CFR 862.1660

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

Casco Standards · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on May 10, 1991 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 later devices descend from it.

Decided: May 10, 1991
Review: 99 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 0

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

This deviceK910440 Document Reflectance II Linearity Test SetCasco Standards · 1991
Descendant · cites it directly · 40 of its ownK023410 Validate Chem 10 Calibration Verification Test Set, Model 110Maine Standards Co. · 2003
Descendant · 2 generations on · 39 of its ownK042318 Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd. · 2004
Descendant · 3 generations on · 14 of its ownK100715 Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd. · 2010
Descendant · 4 generations on · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
Descendant · 5 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2003high 10 (2014) · low 0 (2005)2026

Most influential descendants

Showing 5 of 41 · See all

K023410Validate Chem 10 Calibration Verification Test Set, Model 110Maine Standards Co. · 2003 · cites it directly40descendants
K042318Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd. · 2004 · 2 generations on39descendants
K100715Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd. · 2010 · 3 generations on14descendants
K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · 4 generations on13descendants
K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 5 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K910440	Document Reflectance II Linearity Test Set	Casco Standards	1991	—
+1	K023410	Validate Chem 10 Calibration Verification Test Set, Model 110	Maine Standards Co.	2003	—
+2	K042318	Audit Microcv General Chemistry Linearity Set	Aalto Scientific, Ltd.	2004	—
+3	K100715	Audit Microcv Homocysteine Linearity Set, Model 704M-5	Aalto Scientific, Ltd.	2010	—
+4	K133128	Immulite 2000; HCG Calibration Verification Material, Insulin Calibration…	Siemens Healthcare Diagnostics, Inc.	2013	—
+5	K140258	Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration…	Siemens Healthcare Diagnostics, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2006	1	0
2007	1	0
2008	2	0
2010	5	0
2011	3	0
2012	4	0
2013	4	0
2014	10	0
2015	7	0
2016	1	0
2017	1	0

FIG. 1 — Lineage of K910440, 1991–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJY? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (41)

See all 41

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

Number	Device	Applicant	Decided	Descendants
K023410	Validate Chem 10 Calibration Verification Test Set, Model 110	Maine Standards Co.	2003	40

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, K023410 (Maine Standards Co., 2003) has gone furthest, with 40 descendants of its own.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

https://510kreport.com/device/K910440 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910440: Document Reflectance II Linearity Test Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910440

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026