510(k) · Cleared
ClearedOne Touch Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifescan, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Dec 3, 1992 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 3, 1992
- Review
- 140 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK923544 One Touch Test StripsLifescan, Inc. · 1992
- Descendant · cites it directly · 2 of its ownK113135 Unistrip 1Unistrip Technologies, LLC · 2013
- Descendant · 2 generations on · 1 of its ownK160038 UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK162430 UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK052207 Accurex Glucose Test StripIncline Medical, LLC · 2006
Most influential descendants
Showing 4 of 4 · See all- K113135Unistrip 1Unistrip Technologies, LLC · 2013 · cites it directly2descendants
- K160038UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2016 · 2 generations on1descendant
- K162430UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2017 · 3 generations on0descendants
- K052207Accurex Glucose Test StripIncline Medical, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923544 | One Touch Test Strips | Lifescan, Inc. | 1992 | — |
| +1 | K113135 | Unistrip 1 | Unistrip Technologies, LLC | 2013 | — |
| +2 | K160038 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | 2016 | — |
| +3 | K162430 | UniStrip1 Generic Blood Glucose Test Strips | Ok Biotech Co., Ltd. | 2017 | — |
| +1 | K052207 | Accurex Glucose Test Strip | Incline Medical, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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, K113135 (Unistrip Technologies, LLC, 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K923544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923544: One Touch Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923544
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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