510(k) · Cleared
ClearedIsecure Syringe Cartridge Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · IQG Adaptor, Holder, Syringe
Cleared on Dec 11, 2006 as substantially equivalent to K820164 (Sterling Drug, Inc., 1982) after a 53-day review. Its family tree reaches back 1 generation to 1982. 5 later devices descend from it.
- Decided
- Dec 11, 2006
- Review
- 53 days
- Class
- Class I
- Product code
- IQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K820164 (1982). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK820164 Empty Sterile CarpujectSterling Drug, Inc. · 1982
- This deviceK063180 Isecure Syringe Cartridge HolderHospira, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK180345 Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK190987 Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK083583 Xpresse Injection SystemNordson Efd · 2009
- Descendant · 3 generations on · 0 of its ownK203321 Cystoject Syringe LeverUrogen Pharma, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK131963 Tautona Injector DeviceTautona Group, LLC · 2013
Most influential descendants
Showing 5 of 5 · See all- K180345Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2018 · cites it directly2descendants
- K190987Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2019 · 2 generations on1descendant
- K083583Xpresse Injection SystemNordson Efd · 2009 · cites it directly1descendant
- K203321Cystoject Syringe LeverUrogen Pharma, Ltd. · 2020 · 3 generations on0descendants
- K131963Tautona Injector DeviceTautona Group, LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820164 | Empty Sterile Carpuject | Sterling Drug, Inc. | 1982 | — |
| 0 (this device) | K063180 | Isecure Syringe Cartridge Holder | Hospira, Inc. | 2006 | — |
| +1 | K180345 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | 2018 | — |
| +2 | K190987 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | 2019 | — |
| +1 | K083583 | Xpresse Injection System | Nordson Efd | 2009 | — |
| +3 | K203321 | Cystoject Syringe Lever | Urogen Pharma, Ltd. | 2020 | — |
| +2 | K131963 | Tautona Injector Device | Tautona Group, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
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 |
|---|---|---|---|
| * | K820164 | Empty Sterile CarpujectSummary page 1…5. Predicate Devices: Device Name 510(k) Number Empty Sterile Carpuject® Cartridge K820164 Syringe holder Accessory 6. Proposed Device Description: The proposed change is to combine… | 1982 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All IQG devicesIQG Adaptor, Holder, Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 iSecure Syringe Cartridge Holder is intended for use in the withdrawal and administration of sterile materials under aseptic conditions in accordance with the best judgment of the physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063180: Isecure Syringe Cartridge Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063180
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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