510(k) · Cleared
ClearedVITROS Immunodiagnostic Products Insulin Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · JIT Calibrator, Secondary
Cleared on May 16, 2017 as substantially equivalent to K060359 (Denka Seiken Co., Ltd., 2006) after a 25-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- May 16, 2017
- Review
- 25 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903628 (1990). 5 ancestors in all, the oldest K901212 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK903628 Aia-Pack IriTosoh Corp. · 1990
- 2 generations backK021535 Advia Cantaur and Acs:180 Insulin CalibratorBayer Diagnostics Corp. · 2002 · Recalled
- 1 generation backK060359 Archiect Insulin and Controls, Model 8K41-01, 8K41-10Denka Seiken Co., Ltd. · 2006
- This deviceK171168 VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903628 | Aia-Pack Iri | Tosoh Corp. | 1990 | — |
| −2 | K021535 | Advia Cantaur and Acs:180 Insulin Calibrator | Bayer Diagnostics Corp. | 2002 | 2 |
| −1 | K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10 | Denka Seiken Co., Ltd. | 2006 | — |
| 0 (this device) | K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2003 | 1 | 0 |
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 JIT? 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
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 | Decided |
|---|---|---|---|
| * | K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10Summary page 4…I Product Code: JIT Panel: Clinical Chemistry 6. Predicate Device Device Name Architect Insulin Calibrators 510(k) number: K060359 Manufacturer: Produced for Abbott by Denka Seiken Co., Ltd. 7. Intended Use See Indications for Use… | 2006 |
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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For in vitro diagnostic use only.
For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of insulin in human serum and plasma (Li Heparin).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171168: VITROS Immunodiagnostic Products Insulin Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171168
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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