510(k) · Cleared
ClearedNova Statstrip Lactate Hospital Meter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · KHP Acid, Lactic, Enzymatic Method
Cleared on Jan 5, 2012 as substantially equivalent to K100602 (Nova Biomedical Corp., 2011) after a 93-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jan 5, 2012
- Review
- 93 days
- Class
- Class I
- Product code
- KHP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K913806 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK913806 Ysi Model 2300 Stat PlusYsis, Inc. · 1991
- 2 generations backK980908 Lactate Pro SystemKdk Corp. · 1998
- 1 generation backK100602 Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test…Nova Biomedical Corp. · 2011
- This deviceK112955 Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913806 | Ysi Model 2300 Stat Plus | Ysis, Inc. | 1991 | — |
| −2 | K980908 | Lactate Pro System | Kdk Corp. | 1998 | — |
| −1 | K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips | Nova Biomedical Corp. | 2011 | — |
| 0 (this device) | K112955 | Nova Statstrip Lactate Hospital Meter System | Nova Biomedical Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 KHP? 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 |
|---|---|---|---|
| * | K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsSummary page 2…the same Technological fundamental scientific technology and Intended use as the currently Characteristics: marketed Nova StatStrip Lactate Hospital Meter System (K100602). Both the Nova StatStrip Lactate Hospital Meter System and the proposed Nova StatStrip Lac… | 2011 |
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 4 companies; a new generation was cleared every 6.9 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All KHP devicesKHP Acid, Lactic, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KHP
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · KHP
Too few KHP 510(k)s in any year since 2007 to give a median.
Recalls per year · KHP
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHP
9in 2025
MAUDE reports naming product code KHP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 12 |
| 2014 | 0 | — | 1 | 19 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 3 | 41 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals for multiple patient use in a professional healthcare setting for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. It is not for use on capillary blood…
Read the full statement (236 words)
The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals for multiple patient use in a professional healthcare setting for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. It is not for use on capillary blood specimens. It is intended to provide plasma equivalent results to laboratory methods.
Nova StatStrip Lactate Test Strips are intended for use only with the Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. The performance characteristics of the device for lactate measurements on capillary specimens have not been established. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only).
Nova StatStrip Lactate Control Solutions are intended for use with the Nova StatStrip Lactate Hospital Meter and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls, (Levels 1 and Level 2). Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Lactate Hospital Meter. There are 4 levels of lactate linearity solutions: Level 1, Level 2, Level 3, and Level 4.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112955 · printed Nov 5, 2026
Cite this page
510(k) Report. “K112955: Nova Statstrip Lactate Hospital Meter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112955
Report an extraction error
Are you the manufacturer?
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