510(k) · Cleared
ClearedAia-Pack (R) Prog Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Medics, Inc. · JLS Radioimmunoassay, Progesterone
Cleared on Oct 22, 1993 after a 108-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Oct 22, 1993
- Review
- 108 days
- Class
- Class I
- Product code
- JLS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK933269 Aia-Pack (R) Prog AssayTosoh Medics, Inc. · 1993
- Descendant · cites it directly · 0 of its ownK153417 ST AIA-PACK PROG III Calibrator SetTosoh Bioscience, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK143144 ST AIA-PACK PROG II Calibrator SetTosoh Bioscience, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933269 | Aia-Pack (R) Prog Assay | Tosoh Medics, Inc. | 1993 | — |
| +1 | K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | 2015 | 1 |
| +1 | K143144 | ST AIA-PACK PROG II Calibrator Set | Tosoh Bioscience, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
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 JLS? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K153417 (Tosoh Bioscience, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JLS devicesJLS Radioimmunoassay, Progesterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JLS
FDA has decided no JLS device since 2007.
Median 510(k) review, days · JLS
Too few JLS 510(k)s in any year since 2007 to give a median.
Recalls per year · JLS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLS
3in 2025
MAUDE reports naming product code JLS, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 3 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 1 | 41 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K933269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933269: Aia-Pack (R) Prog Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933269
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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