510(k) · Cleared
ClearedInsulin Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicool, Inc. · IQG Adaptor, Holder, Syringe
Cleared on Jul 11, 2008 as substantially equivalent to K072174 (41 Industries, LLC, 2008) after a 206-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Jul 11, 2008
- Review
- 206 days
- Class
- Class I
- Product code
- IQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072174 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK072174 Insucozi Insulin Vial Cover41 Industries, LLC · 2008
- This deviceK073555 Insulin ProtectorMedicool, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072174 | Insucozi Insulin Vial Cover | 41 Industries, LLC | 2008 | — |
| 0 (this device) | K073555 | Insulin Protector | Medicool, Inc. | 2008 | — |
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 IQG? 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
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 | Decided |
|---|---|---|---|
| * | K072174 | Insucozi Insulin Vial Cover Cleared while this submission was under review Summary page 2…n organs, fluids, or tissue in any form. This device's target population is people who require insulin. lll. Summary of Similar Technological Characteristics Insucozi (K072174) IV. Discussion and Conclusions of Submitted Testing In the durability experiment (Nonclinical Test: Verification Testing Of Coo… | 2008 |
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 IQG devicesIQG Adaptor, Holder, Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IQG
2in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · IQG
Too few IQG 510(k)s in any year since 2007 to give a median.
Recalls per year · IQG
No recall names IQG since 2007.
Adverse event reports per year · IQG
2in 2025
MAUDE reports naming product code IQG, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Insulin Protector is designed to protect bottles of insulin while keeping them cool. It is not designed to carry or store human organs, fluids, or tissue in any form.
This device's target population is people who require insulin.
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/K073555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073555: Insulin Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073555
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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