510(k) Report

510(k) · Cleared

Cleared

POGO Automatic Blood Glucose Monitoring System

K162203510(k) TraditionalCleared Apr 6, 2017244-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

Intuity Medical, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Apr 6, 2017 as substantially equivalent to K130265 (Bayer Healthcare, LLC, 2014) after a 244-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.

Decided
Apr 6, 2017
Review
244 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K062058 (2006). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant clearedK062058 · Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 · Bayer Healthcare · 2006 · recalledK111268 · Contour (R) Next Blood Glucose Monitoring System · Bayer Healthcare · 2012 · recalledK130265 · Contour Next EZ Blood Glucose Meter · Bayer Healthcare, LLC · 201420052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K130265 · Contour Next EZ Blood Glucose Meter · Bayer Healthcare, LLC · 2014K111268 · Contour (R) Next Blood Glucose Monitoring System · Bayer Healthcare · 2012 · recalledK062058 · Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 · Bayer Healthcare · 2006 · recalled0
  1. Root · 3 generations backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
  2. 2 generations backK111268 Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare · 2012 · Recalled
  3. 1 generation backK130265 Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC · 2014
  4. This deviceK162203 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2017
  5. Descendant · cites it directly · 0 of its ownK181316 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K181316POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K062058Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Bayer Healthcare20062
−2K111268Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare20121
−1K130265Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC2014—
0 (this device)K162203POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.2017—
+1K181316POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K162203, 2006–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K130265Contour Next EZ Blood Glucose Meter
Summary page 4
…ystem is substantially equivalent to the Contour Next EZ Blood Glucose Monitoring System (Bayer HealthCare LLC, Mishawaka, IN), cleared under k130265 on June 23, 2014. T 408.530.1700 F 408.530.1717 W intuitymedical.com Page 1 ~~~~~ 5…
Bayer Healthcare, LLC2014—

Also cleared against K130265: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K181316POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20180

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 11 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K181316 (Intuity Medical, Inc., 2018) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K130265.

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. 2017, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

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

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
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

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The POGO Automatic Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The POGO Automatic Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes…

Read the full statement (153 words)

The POGO Automatic Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The POGO Automatic Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The POGO Automatic 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 control. The POGO Automatic Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The POGO Automatic Blood Glucose Monitoring System is indicated for use in adults and adolescents (13 and up).

POGO Automatic Test Cartridges are for use with the POGO Automatic Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Indications for use as stated in the FDA summary.

Also cleared against K130265

1 other device cites the same predicate.

  • K162336Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2017

More from Intuity Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K181316POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2018
  • K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K162203 · printed Nov 5, 2026

Cite this page

510(k) Report. “K162203: POGO Automatic 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/K162203

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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