510(k) · Decided
DecidedMon-a-Therm Foley Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Medical · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cleared on May 27, 1993 after a 315-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.
- Decided
- May 27, 1993
- Review
- 315 days
- Class
- Class II
- Product code
- FCM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK923538 Mon-a-Therm Foley KitMallinckrodt Medical · 1993
- Descendant · cites it directly · 0 of its ownK062977 Critiview, Model CRV3Critisense, Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062977Critiview, Model CRV3Critisense, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923538 | Mon-a-Therm Foley Kit | Mallinckrodt Medical | 1993 | — |
| +1 | K062977 | Critiview, Model CRV3 | Critisense, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 FCM? 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 FCM device
- #1 K254076 BD Touchless™ Plus Unisex Pre-Lubricated…score 11.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062977 | Critiview, Model CRV3 | 2007 | 0 |
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, K062977 (Critisense, Ltd., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FCM devicesFCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCM
Too few FCM 510(k)s in any year since 2007 to give a median.
Recalls per year · FCM
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FCM
35in 2025
MAUDE reports naming product code FCM, 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 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 31 | 4 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 61 |
| 2019 | 0 | — | 0 | 79 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 85 |
| 2022 | 0 | — | 6 | 59 |
| 2023 | 1 | — | 1 (1) | 48 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K923538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923538: Mon-a-Therm Foley Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923538
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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