510(k) · Cleared
ClearedMedisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Sep 9, 2002 as substantially equivalent to K944195 (Medisense, Inc., 1995) and 1 other predicate after a 68-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Sep 9, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945887 (1995). 8 ancestors in all, the oldest K896951 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 3 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 2 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 1 generation backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- This deviceK022182 Medisense Precision Easyblood Glucose Monitoring System, Medisense…Abbott Laboratories · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −3 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −2 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −1 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| 0 (this device) | K022182 | Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium… | Abbott Laboratories | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K944195 | Quickpro Blood Glucose Testing SystemSummary page 1…System Classification: Glucose Test System Class I1 per 2 1 CFR 862.1345 Predicate Device: Precision QID@Blood Glucose Testing System, K944195, K9718 12, Description: The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monito… | 1995 |
| * | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripSummary page 1…Classification: Glucose Test System Class I1 per 2 1 CFR 862.1345 Predicate Device: Precision QID@Blood Glucose Testing System, K944195, K9718 12, Description: The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring Syste… | 1997 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K944195.
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.
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 MediSense Precision Easy / MediSense Oprium Easy Blood Glucose Monitoring System is intended for outside-rhe-body (in-virro diugqosric) use. The system is indicated for the quantirative measilremenr of glucose in fresh whole blood for self-tesring by lay users (e-g., from the finger), or by health care professionals. The MediSense Precision Easy / MediSense Oprium Easy Blood Glucose Monitoring System is to be used for the moniroring of blood glucose concentrations in persons with diabetes and other condirions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022182: Medisense Precision Easyblood Glucose Monitoring System, Medisense Optium Easyblood 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/K022182
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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