510(k) · Cleared
ClearedPymah Cold Sterilog Glutaraldehyde Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pymah Corp. · MED Sterilant, Medical Devices
Cleared on Jul 28, 1992 after a 256-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 28, 1992
- Review
- 256 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK915170 Pymah Cold Sterilog Glutaraldehyde MonitorPymah Corp. · 1992
- Descendant · cites it directly · 2 of its ownK092346 Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171Serim Research Corp. · 2010
- Descendant · 2 generations on · 1 of its ownK103126 Trophon Chemical IndicatorNanosonics Limited · 2011
- Descendant · 3 generations on · 0 of its ownK233413 Ultraphon Chemical Indicator (TRO-T and TRO-B)True Indicating, LLC · 2024
- Descendant · cites it directly · 0 of its ownK080750 Browne Rapicide Glutaraldehyde IndicatorSTERIS Corporation · 2008
- Descendant · cites it directly · 0 of its ownK992341 Cidex Opa Solution Test StripSerim Research Corp. · 1999
Most influential descendants
Showing 5 of 5 · See all- K092346Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171Serim Research Corp. · 2010 · cites it directly2descendants
- K103126Trophon Chemical IndicatorNanosonics Limited · 2011 · 2 generations on1descendant
- K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)True Indicating, LLC · 2024 · 3 generations on0descendants
- K080750Browne Rapicide Glutaraldehyde IndicatorSTERIS Corporation · 2008 · cites it directly0descendants
- K992341Cidex Opa Solution Test StripSerim Research Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915170 | Pymah Cold Sterilog Glutaraldehyde Monitor | Pymah Corp. | 1992 | — |
| +1 | K092346 | Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171 | Serim Research Corp. | 2010 | — |
| +2 | K103126 | Trophon Chemical Indicator | Nanosonics Limited | 2011 | — |
| +3 | K233413 | Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC | 2024 | — |
| +1 | K080750 | Browne Rapicide Glutaraldehyde Indicator | STERIS Corporation | 2008 | — |
| +1 | K992341 | Cidex Opa Solution Test Strip | Serim Research Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2024 | 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 MED? 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 MED device
- #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 generations · 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? (5)
3 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, K092346 (Serim Research Corp., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 2025
MAUDE reports naming product code MED, 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 | — | 3 | 34 |
| 2008 | 1 | — | 2 | 79 |
| 2009 | 0 | — | 0 | 158 |
| 2010 | 6 | 281 | 0 | 89 |
| 2011 | 0 | — | 2 | 106 |
| 2012 | 3 | 111 | 0 | 337 |
| 2013 | 1 | — | 0 | 140 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 110 |
| 2016 | 1 | — | 0 | 135 |
| 2017 | 1 | — | 0 | 74 |
| 2018 | 2 | — | 0 | 42 |
| 2019 | 4 | 84 | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 2 | — | 0 | 31 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K915170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915170: Pymah Cold Sterilog Glutaraldehyde Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915170
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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