510(k) · Cleared
ClearedHuman Subcutaneous Injector, Model Hsi 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Felton International, Inc. · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Jun 24, 2004 as substantially equivalent to K013256 (Felton International, Inc., 2001) after a 42-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 24, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945543 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK945543 Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000…Intersect Medical Products, Inc. · 1994
- 1 generation backK013256 BI-3M Needle-Free Injector SystemFelton International, Inc. · 2001
- This deviceK041280 Human Subcutaneous Injector, Model Hsi 500Felton International, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945543 | Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y… | Intersect Medical Products, Inc. | 1994 | — |
| −1 | K013256 | BI-3M Needle-Free Injector System | Felton International, Inc. | 2001 | — |
| 0 (this device) | K041280 | Human Subcutaneous Injector, Model Hsi 500 | Felton International, Inc. | 2004 | — |
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 KZE? 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? (2)
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 |
|---|---|---|---|
| * | K013256 | BI-3M Needle-Free Injector SystemSummary page 1…: Human Subcutaneous Injector system Common Name: Needle-free fluid injection system Classification Name: Nonelectrically powered fluid injector Predicate Devices: K013256 Felton International's Bi-3M Preamendment Ped-O-Jet Device Description: The Human Subcutaneous Injector… | 2001 |
| * | — | Ped-O-Jet Named without a submission number |
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 10 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All KZE devicesKZE Injector, Fluid, Non-Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZE
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KZE
220in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KZE
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZE
1in 2025
MAUDE reports naming product code KZE, 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 | 54 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 4 | 220 | 0 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This needle-free fluid injector system is indicated for the delivery of vaccines or medications to the subcutaneous tissue by penetrating the skin under high pressure. This device is to be used by a health care professional only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041280: Human Subcutaneous Injector, Model Hsi 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041280
Report an extraction error
Are you the manufacturer?
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