510(k) · Cleared
ClearedCera-Chek 1070 Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceragem Medisys, Inc. · LFR Glucose Dehydrogenase, Glucose
Cleared on Feb 28, 2014 as substantially equivalent to K062058 (Bayer Healthcare, 2006) after a 261-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- Feb 28, 2014
- Review
- 261 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062058 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
- This deviceK131727 Cera-Chek 1070 Blood Glucose Monitoring SystemCeragem Medisys, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK141829 Glucovitaal H1A Blood Glucose Monitoring SystemCeragem Medisys, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141829Glucovitaal H1A Blood Glucose Monitoring SystemCeragem Medisys, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 | Bayer Healthcare | 2006 | 2 |
| 0 (this device) | K131727 | Cera-Chek 1070 Blood Glucose Monitoring System | Ceragem Medisys, Inc. | 2014 | — |
| +1 | K141829 | Glucovitaal H1A Blood Glucose Monitoring System | Ceragem Medisys, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Summary page 1…below. (1) Device Name: Ascensia® CONTOUR 0 Blood Glucose Monitoring System (2) Manufacturer: Bayer IlealthCare. LLC. (3) 510(K) Number: K062058 5. Device Description The CERA-CH-EK 1070 Blood Glucose Monitoring System consists of the CERA-CH-EK 1070… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141829 | Glucovitaal H1A Blood Glucose Monitoring System | 2014 | 0 |
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?
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in flesh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing…
Read the full statement (276 words)
The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in flesh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The CERA-CHEK 1070 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 controls. The CERA-CHEK 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The CERA-CHEK 1070 Blood Glucose Test Strips are for use with the CERA-CHEK 1070 Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.
The CERA-CHEK 1070 Control Solution is for use with the CERA-CHEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verif that the meter and test strips are working together properly and that the test is performing correctly.
The CERA-CHEK Diabetes Management Software is PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose results for effective diabetes management. It is intended for use as an accessory to compatible CERAGEM MEDISYS blood glucose monitoring systems. The CERA-CHEK Diabetes Management Software's language is English.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131727: Cera-Chek 1070 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/K131727
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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