510(k) · Cleared

Cleared

StatStrip Xpress Blood Glucose Monitoring System

K160156510(k) TraditionalCleared Jun 23, 2016153-day reviewClass II21 CFR 862.1345

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nova Biomedical Corporation · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jun 23, 2016 as substantially equivalent to K070255 (Nova Biomedical Corp., 2007) after a 153-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.

Decided: Jun 23, 2016
Review: 153 days
Class: Class II
Product code: NBW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K070255 (2007). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK070255 Nova Max Blood Glucose Monitor System, 90001,90002Nova Biomedical Corp. · 2007
This deviceK160156 StatStrip Xpress Blood Glucose Monitoring SystemNova Biomedical Corporation · 2016
Descendant · cites it directly · 0 of its ownK170464 StatStrip Xpress Blood Glucose Monitoring SystemNova Biomedical Corporation · 2017

Most influential descendants

Showing 1 of 1 · See all

K170464StatStrip Xpress Blood Glucose Monitoring SystemNova Biomedical Corporation · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K070255	Nova Max Blood Glucose Monitor System, 90001,90002	Nova Biomedical Corp.	2007	—
0 (this device)	K160156	StatStrip Xpress Blood Glucose Monitoring System	Nova Biomedical Corporation	2016	—
+1	K170464	StatStrip Xpress Blood Glucose Monitoring System	Nova Biomedical Corporation	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K160156, 2007–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K070255	Nova Max Blood Glucose Monitor System, 90001,90002 Summary page 4 …oduct Code: NBW, JJX, CGA Class: II, I (reserved), II Predicate Device: Nova Max Blood Glucose Monitor System, K070255 Reference Device: StatStrip Xpress Glucose Hospital Meter System, K150461 Device Description: The StatStrip Xpre…	Nova Biomedical Corp.	2007	—
†	K150461	StatStrip Xpress Glucose Hospital Meter System	Nova Biomedical Corporation	2015	—

Also cleared against K070255: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K170464	StatStrip Xpress Blood Glucose Monitoring System	Nova Biomedical Corporation	2017	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?

Its one ancestor has no recall.
Of its descendants, K170464 (Nova Biomedical Corporation, 2017) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K070255.

How does its category compare?

All NBW devices

NBW 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

2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007high 465 (2021) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBW

1in 2025

2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007high 76,621 (2016) · low 4,745 (2025)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 StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes…

Read the full statement (170 words)

The StatStrip Xpress Blood Glucose Monitoring System is intended to be used for the quantitative measurement of

glucose in fresh capillary whole blood obtained from the fingertip. It is intended for single-patient home use and should

not be shared. It is intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the

effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for

use with neonates.

The StatStrip Xpress Blood Glucose Monitoring System comprises the StatStrip Xpress Blood Glucose Monitor, StatStrip

Xpress Glucose Test Strips, and StatStrip Xpress Glucose Control Solutions. The StatStrip Xpress Glucose Control

Solutions are intended for use with the StatStrip Xpress Blood Glucose Monitoring System as a quality control check to

verify the accuracy of blood glucose test results. There are 3 levels of controls (Levels 1, 2, and 3).

• The StatStrip Xpress Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic

use).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160156 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160156: StatStrip Xpress Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160156

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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