510(k) · Cleared
ClearedPOGO Automatic Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuity Medical, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 25, 2016 as substantially equivalent to K081389 (Roche Diagnostics, 2008) and 1 other predicate after a 237-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Apr 25, 2016
- Review
- 237 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K945887 (1995). 37 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 6 generations between
- 3 generations backK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
- 2 generations backK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
- 1 generation backK123851 Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
- This deviceK152493 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 9 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 8 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 7 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 6 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 5 generations backK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- 4 generations backK060706 Liberty Normal Glucose Control SolutionLiberty Healthcare Group, Inc. · 2006
- 3 generations backK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
- 2 generations backK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
- 1 generation backK123851 Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
- This deviceK152493 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −9 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −8 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −7 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −6 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −5 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| −4 | K060706 | Liberty Normal Glucose Control Solution | Liberty Healthcare Group, Inc. | 2006 | — |
| −3 | K070506 | SMS Multi Glucose Control, Model 2120049 | Medical Specialties Supply Co., Inc. | 2007 | — |
| −2 | K081403 | Glucose Meter-Check Control Solution for Roche Accu-Chek | Bionostics, Inc. | 2008 | — |
| −1 | K123851 | Glucose Meter-Check Solution for Roche Accu-Chek | Bionostics, Inc. | 2013 | — |
| 0 (this device) | K152493 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K081389 | Accu-Chek Compact Plus Blood Glucose Monitoring SystemSummary page 4…substantially equivalent to the Accu-Chek Compact Plus Blood Glucose Monitoring System (Roche Diagnostics, Inc., Indianapolis, IN), cleared under k081389 on July 15, 2008. The POGO Control Solutions are substantially equivalent to Glucose Meter-Check®… | 2008 |
| * | K123851 | Glucose Meter-Check Solution for Roche Accu-ChekSummary page 4…The POGO Control Solutions are substantially equivalent to Glucose Meter-Check® Solution Roche Accu-Chek (Bionostics, Inc., Devens, MA), cleared under k123851 on February 14, 2013. T 408.530.1700 F 408.530.1717 W intuitymedical.com… | 2013 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 37 ancestors have a recall of any class.
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. 2016, 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 POGO Automatic 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. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The POGO Automatic Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes…
Read the full statement (184 words)
The POGO Automatic 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. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The POGO Automatic 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 POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).
POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
POGO Control Solutions are used with the POGO Automatic Meter to indicate appropriate user technique and to indicate that the POGO Automatic Test Cartridge and POGO Automatic Meter are functioning properly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152493: POGO Automatic Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152493
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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