510(k) · Cleared
ClearedOkmeter Direct Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ok Biotech Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 14, 2014 as substantially equivalent to K090609 (Ok Biotech Co., Ltd., 2010) after a 357-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Aug 14, 2014
- Review
- 357 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042005 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
- 3 generations backK060467 Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
- 2 generations backK073118 Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
- 1 generation backK090609 Okmeter Match Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2010
- This deviceK132633 Okmeter Direct Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042005 | Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 | Taidoc Technology Corporation | 2004 | — |
| −3 | K060467 | Prodigy Blood Glucose Test System | Diagnostic Devices, Inc. | 2006 | — |
| −2 | K073118 | Prodigy Voice Blood Glucose Monitoring System | Diagnostic Devices, Inc. | 2008 | — |
| −1 | K090609 | Okmeter Match Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2010 | — |
| 0 (this device) | K132633 | Okmeter Direct Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2014 | — |
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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 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? (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 |
|---|---|---|---|
| * | K090609 | Okmeter Match Blood Glucose Monitoring SystemSummary page 4…ety and Effectiveness Information Predicate Device: Claim of Substantial Equivalence (SE) is made to Okmeter Match Blood Glucose Monitoring System (K090609) Device Description: Based on an electrochemical biosensor technology and the principle of capillary action, Okmete… | 2010 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The OKmeter Direct Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm. The OKmeter Direct Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The OKmeter Direct Blood Glucose Monitoring System is intended for self-testing outside the body (in…
Read the full statement (165 words)
The OKmeter Direct Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm. The OKmeter Direct Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The OKmeter Direct Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OKmeter Direct Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The OKmeter Direct Test Strips are for use with the OKmeter Direct Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper-arm, calf, thigh, or palm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132633 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132633: Okmeter Direct Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132633
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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