510(k) · Cleared

Cleared

DEKA Loop

K234055510(k) TraditionalCleared Mar 13, 202482-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

Deka Research and Development · QJI Interoperable Automated Glycemic Controller

Cleared on Mar 13, 2024 as substantially equivalent to K203689 (Tidepool Project, 2023) after an 82-day review. Its family tree reaches back 3 generations to 2019.

Decided: Mar 13, 2024
Review: 82 days
Class: Class II
Product code: QJI
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to DEN190034 (2019). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backDEN190034 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2019
2 generations backK200467 Control-IQ TechnologyTandem Diabetes Care, Inc. · 2020
1 generation backK203689 Tidepool LoopTidepool Project · 2023
This deviceK234055 DEKA LoopDeka Research and Development · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	DEN190034	Control-IQ Technology	Tandem Diabetes Care, Inc.	2019	—
−2	K200467	Control-IQ Technology	Tandem Diabetes Care, Inc.	2020	—
−1	K203689	Tidepool Loop	Tidepool Project	2023	—
0 (this device)	K234055	DEKA Loop	Deka Research and Development	2024	—

FIG. 1 — Lineage of K234055, 2019–2024Source: 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 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 K253701 SmartGuard Technology; Predictive Low Glucose…score 17.1 · 12 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
*	K203689	Tidepool Loop Summary page 4 …tion: 21 CFR 862.1356 Product Code: QJI Class: II Device Panel: Clinical Chemistry Predicate Device The predicate device for this submission is Tidepool Loop cleared in K203689. Device Description DEKA Loop is an interoperable Alternate Glycemic Controller (iAGC) and works to control an ACE (Alternate Co…	Tidepool Project	2023	—

Also cleared against K203689: 1 other 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.

What does this lineage say?

The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K203689.

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

2007high 8 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJI

130in 2025

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	1	—	1
2021	0	—	1
2022	2	—	4
2023	4	251	26
2024	4	174	15
2025	5	130	3
2026	8	65	—

What is it indicated for?

DEKA Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and the DEKA alternate

controller enabled (ACE) insulin infusion pump to automatically increase, decrease, and suspend delivery of basal insulin

based on iCGM readings and predicted glucose values. It can also recommend, and with the user’s confirmation, control

the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds.

DEKA Loop is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater.

DEKA Loop is intended for single patient use and requires a prescription.

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/K234055 · printed Nov 5, 2026

Cite this page

510(k) Report. “K234055: DEKA Loop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234055

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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