510(k) · Cleared

Cleared

Unistrip 1

K113135510(k) TraditionalCleared Nov 6, 2013744-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

Unistrip Technologies, LLC · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Nov 6, 2013 as substantially equivalent to K923544 (Lifescan, Inc., 1992) after a 744-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.

Decided: Nov 6, 2013
Review: 744 days
Class: Class II
Product code: NBW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K923544 (1992). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK923544 One Touch Test StripsLifescan, Inc. · 1992
This deviceK113135 Unistrip 1Unistrip Technologies, LLC · 2013
Descendant · cites it directly · 1 of its ownK160038 UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2016
Descendant · 2 generations on · 0 of its ownK162430 UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2017

Most influential descendants

Showing 2 of 2 · See all

K160038UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2016 · cites it directly1descendant
K162430UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd. · 2017 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923544	One Touch Test Strips	Lifescan, Inc.	1992	—
0 (this device)	K113135	Unistrip 1	Unistrip Technologies, LLC	2013	—
+1	K160038	UniStrip1 Generic Blood Glucose Test Strips	Ok Biotech Co., Ltd.	2016	—
+2	K162430	UniStrip1 Generic Blood Glucose Test Strips	Ok Biotech Co., Ltd.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0

FIG. 1 — Lineage of K113135, 1992–2017Source: 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
*	K923544	One Touch Test Strips Summary page 1 …hemistry Predicate Device: Manufacturer Brand Name 510(k) Number Lifescan, Inc. OneTouchO Test Strips K923544 Device Description The UniStripl Test Strips are used with the OneTouchO UltraO, OneTouchl Ultra2l, OneToucho UltraMiniO and One…	Lifescan, Inc.	1992	—

Also cleared against K923544: 1 other device →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K160038	UniStrip1 Generic Blood Glucose Test Strips	Ok Biotech Co., Ltd.	2016	1

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, K160038 (Ok Biotech Co., Ltd., 2016) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K923544.

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. 2013, 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 Unistripi Test Strips are used with the OneTouch® Ultra®. OneTouchi Ultra2a. One-Fouch®o Ultralvini® and One-Touch® UltraSmart® meters purchased before October 2012, set at calibration code 49, for measuring glucose (sugar) in whole capillary blood. The Unistripl is meant for self-testing of blood glucose as an aid to monitor the effectiveness of diabetes control. They are for single patient use only and should not be shared. They are used to…

Read the full statement (181 words)

They are for single patient use only and should not be shared.

They are used to quantitatively measure glucose in fresh capillary whole blood samples taken from the finger, palm, or forearmn.

Testing is done outside the body (in vitro diagnostic use).

They are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.

Not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.

UniStrip I Test Strips allow alternate site testing (AST) from the finqertip, palm and/or the forearm. (Use of palm AST is not to be done with OneTouch®Ultra meter). Alternative site testing should only be done during steady-state times (when glucose is not changing rapidly).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113135 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113135: Unistrip 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113135

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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