510(k) · Cleared
ClearedBI-3M Needle-Free Injector System
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 Dec 7, 2001 as substantially equivalent to K945543 (Intersect Medical Products, Inc., 1994) after a 67-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Dec 7, 2001
- Review
- 67 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945543 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK945543 Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000…Intersect Medical Products, Inc. · 1994
- This deviceK013256 BI-3M Needle-Free Injector SystemFelton International, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK041280 Human Subcutaneous Injector, Model Hsi 500Felton International, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K041280Human Subcutaneous Injector, Model Hsi 500Felton International, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945543 | Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y… | Intersect Medical Products, Inc. | 1994 | — |
| 0 (this device) | K013256 | BI-3M Needle-Free Injector System | Felton International, Inc. | 2001 | — |
| +1 | K041280 | Human Subcutaneous Injector, Model Hsi 500 | Felton International, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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 |
|---|---|---|---|
| * | K945543 | Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y Filter…Summary page 1…fluid injector system Classification Name: Nonelectrically powered fluid injector (Title 21 CFR §880.5430) Predicate Devices: Ped-O-Jet (preamendment device) MEDIiVAX (K9455438) C. Description of the Device: The Bi-3M Needle-Free Injector System consists of a hand-held injector unit to which a multiple… | 1994 |
| * | — | Ped-O-Jet Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041280 | Human Subcutaneous Injector, Model Hsi 500 | 2004 | 0 |
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.
- Of its descendants, K041280 (Felton International, Inc., 2004) has gone furthest, with 0 descendants of its own.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013256: BI-3M Needle-Free Injector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013256
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026