510(k) Report

PMA · Approved

Approved

Glucowatch G2 Biographer

P990026/S019PMAApproved Aug 28, 200352-day reviewClass III

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

Animas Corp. · NCT Instrument, Glucose, Noninvasive Technology

Approved on Aug 28, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 52-day review.

Decided
Aug 28, 2003
Review
52 days
Class
Class III
Product code
NCT
Recalls
None

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

FIG. 1 — Lineage of P990026/S019Source: FDA PMA database · How lineage is built

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

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NCT? 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
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Does it have a predicate?

PMA decisions do not claim a predicate device.

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.

How does its category compare?

All NCT devices

NCT Instrument, Glucose, Noninvasive Technology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NCT

FDA has decided no NCT device since 2007.

Median 510(k) review, days · NCT

Too few NCT 510(k)s in any year since 2007 to give a median.

Recalls per year · NCT

No recall names NCT since 2007.

Adverse event reports per year · NCT

3in 2024

2007: 12010: 12024: 3
2007high 3 (2024) · low 0 (2008)2025

MAUDE reports naming product code NCT, 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
20070—01
20080—00
20090—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—03
20250—00
20260—0—

More from Animas Corp.

63 FDA decisions under this applicant name. See the company

Recent decisions in NCT

The NCT category page

  • P990026/S022Glucowatch G2 BiographerAnimas Corp. · 2004
  • P990026/S021Glucowatch G2 BiographerAnimas Corp. · 2004
  • P990026/S018Glucowatch G2 Biographer: Modified Glucowatch G2 Biographer & AutosensorAnimas Corp. · 2003
  • P990026/S020Glucowatch Automatic Glucose BiographerAnimas Corp. · 2003
  • P990026Glucowatch Automatic Glucose BiographerAnimas Corp. · 2001

https://510kreport.com/device/P990026/S019 · printed Nov 6, 2026

Cite this page

510(k) Report. “P990026/S019: Glucowatch G2 Biographer.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990026/S019

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026