510(k) · Cleared

Cleared

Exactech RSG Blood Glucose Testing System

K961337510(k) TraditionalCleared Jun 21, 199674-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

Medisense, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Jun 21, 1996 as substantially equivalent to K863468 (Travenol Laboratories, S.A., 1986) after a 74-day review. Its family tree reaches back 1 generation to 1986.

Decided: Jun 21, 1996
Review: 74 days
Class: Class II
Product code: CGA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K863468 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK863468 Exactech (TM)Travenol Laboratories, S.A. · 1986
This deviceK961337 Exactech RSG Blood Glucose Testing SystemMedisense, Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863468	Exactech (TM)	Travenol Laboratories, S.A.	1986	—
0 (this device)	K961337	Exactech RSG Blood Glucose Testing System	Medisense, Inc.	1996	—

FIG. 1 — Lineage of K961337, 1986–1996Source: 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 CGA? 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 CGA device

#1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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
*	K863468	Exactech (TM) Summary page 1 …18, 1996 ExacTech RSG Blood Glucose Testing System Blood Glucose Test System “Glucose Test System” - Class II per CFR 862.1345 ExacTech Blood Glucose Testing System - K863468 The ExacTech RSG Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in wh…	Travenol Laboratories, S.A.	1986	—

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 CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007high 6 (2010) · low 0 (2012)2026

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

Adverse event reports per year · CGA

59in 2025

2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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	7	122	2	29
2008	6	56	2	37
2009	10	155	4	75
2010	8	122	6	172
2011	9	217	3	423
2012	10	123	0	233
2013	3	441	3	172
2014	5	265	2	122
2015	4	150	6 (2)	155
2016	4	157	2	36
2017	2	—	0	92
2018	2	—	0	69
2019	2	—	1	116
2020	2	—	0	68
2021	1	—	0	48
2022	1	—	0	272
2023	4	249	3	1,141
2024	2	—	0	266
2025	0	—	0	59
2026	1	—	0	—

What is it indicated for?

The ExacTech RSG Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The product is designed for home or professional use.

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/K961337 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961337: Exactech RSG Blood Glucose Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961337

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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