510(k) Report

510(k) · Cleared

Cleared

CamAPS FX

K232603510(k) TraditionalCleared May 23, 2024269-day reviewClass II21 CFR 862.1356

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

Camdiab, Ltd. · QJI Interoperable Automated Glycemic Controller

Cleared on May 23, 2024 after a 269-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
May 23, 2024
Review
269 days
Class
Class II
Product code
QJI
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2026: 1 descendant cleared2020202220242026
  1. This deviceK232603 CamAPS FXCamdiab, Ltd. · 2024
  2. Descendant · cites it directly · 0 of its ownK261896 iOS CamAPS FXCamDiab · 2026

Most influential descendants

Showing 1 of 1 · See all
  • K261896iOS CamAPS FXCamDiab · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K232603CamAPS FXCamdiab, Ltd.2024—
+1K261896iOS CamAPS FXCamDiab2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K232603, 2024–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Planning a device in QJI? 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 QJI device

  1. #1 K253701 SmartGuard Technology; Predictive Low Glucose…score 17.1 · 12 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K261896iOS CamAPS FXCamDiab20260

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?

  • Of its descendants, K261896 (CamDiab, 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All QJI devices

QJI Interoperable Automated Glycemic Controller: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · QJI

8so far in 2026, the most since 2007

2019: 12020: 12022: 22023: 42024: 42025: 52026 (partial year): 8
2007high 8 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJI

130in 2025

2023: 251 days median2024: 174 days median2025: 130 days median2026 (partial year): 65 days median
2007high 251 (2023) · low 130 (2025)2026

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

Recalls per year · QJI

No recall names QJI since 2007.

Adverse event reports per year · QJI

3in 2025

2020: 12021: 12022: 42023: 262024: 152025: 3
2007high 26 (2023) · low 0 (2007)2025

MAUDE reports naming product code QJI, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20201—01
20210—01
20222—04
20234251026
20244174015
2025513003
20268650—

What is it indicated for?

CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). Additional age and other restrictions may apply depending on the chosen continuous glucose monitor and insulin pump.

CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfil its intended use. The list of supported insulin pumps and CGMs is provided in the User Manual.

CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that the linked continuous glucose monitoring system is suitable for use in pregnancy.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in QJI

The QJI category page

  • K262576twiist Loop AlgorithmDeka Research and Development Corp. · 2026
  • K261896iOS CamAPS FXCamDiab · 2026
  • K262763iLet Dosing Decision SoftwareBeta Bionics, Inc. · 2026
  • K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed · 2026
  • K261461Omnipod 6 algorithmInsulet Corporation · 2026

https://510kreport.com/device/K232603 · printed Nov 5, 2026

Cite this page

510(k) Report. “K232603: CamAPS FX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232603

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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