510(k) · Cleared
ClearedLiberty Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymedica Pharmaceuticals, U.S.A., Inc.] · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Feb 19, 2002 as substantially equivalent to K993829 (Roche Diagnostics Corp., 1999) after a 62-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Feb 19, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993829 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993829 Accu-Chek Simplicity SystemRoche Diagnostics Corp. · 1999
- This deviceK014167 Liberty Blood Glucose Monitoring SystemPolymedica Pharmaceuticals, U.S.A., Inc.] · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993829 | Accu-Chek Simplicity System | Roche Diagnostics Corp. | 1999 | — |
| 0 (this device) | K014167 | Liberty Blood Glucose Monitoring System | Polymedica Pharmaceuticals, U.S.A., Inc.] | 2002 | — |
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 |
|---|---|---|---|
| * | K993829 | Accu-Chek Simplicity SystemSummary page 1…: Glucose Test System (21 CFR 862.1345) Predicate device | We claim substantial equivalence 1o the Accu-check Simplicity|System markercd by Roche Diagnostics, 51 0(k) # K993829 Device The Liberty™ Blood Glucose Monitering System consists of the following elements: test strips; a battery operated, portable… | 1999 |
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?
- Its one ancestor has no 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.
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 Liberty™ Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. The Liberty™ Blood Glucose Meter is intended for use with Liberty™ Blood Glucose Strips for the quantitative measurement of glucose in fresh capillary whole…
Read the full statement (249 words)
The Liberty™ Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
The Liberty™ Blood Glucose Meter is intended for use with Liberty™ Blood Glucose Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
Liberty™ Blood Glucose Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Liberty™ Blood Glucose Meter. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control.
Liberty™ Control Solution is an aqueous glucose solution for use with the Liberty™ Blood Glucose System. It is used as a quality control check to verify the accuracy of the blood glucose test result. The Liberty™ Control Solution is intended for use in the validation of the performance of the Blood Glucose System by providing a test solution with a known range of glucose. A control test that falls within the acceptable range indicates the user’s technique is appropriate and the test strip and meter are functioning properly.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014167 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014167: Liberty Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014167
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026