510(k) · Cleared
ClearedPharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis Reset Stati
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmajet, Inc. · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Jul 27, 2011 as substantially equivalent to K081532 (Pharmajet, Inc., 2009) after a 55-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jul 27, 2011
- Review
- 55 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920631 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK920631 Bioject Jet Injection SystemBioject, Inc. · 1994
- 2 generations backK960373 Biojector 2000 Model 1B02000Bioject, Inc. · 1997
- 1 generation backK081532 Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009
- This deviceK111517 Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01…Pharmajet, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920631 | Bioject Jet Injection System | Bioject, Inc. | 1994 | — |
| −2 | K960373 | Biojector 2000 Model 1B02000 | Bioject, Inc. | 1997 | — |
| −1 | K081532 | Pharmajet Needle-Free Injection System | Pharmajet, Inc. | 2009 | — |
| 0 (this device) | K111517 | Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis… | Pharmajet, Inc. | 2011 | — |
Other ancestors 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? (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 |
|---|---|---|---|
| * | K081532 | Pharmajet Needle-Free Injection SystemSummary page 2…ents of the PharmaJet® System are unique and cannot be used with any other needle-free system. The Predicate device, the PharmaJet® 0.5 mL Needle-free Injection system (K081 532) is a compact, spring-loaded needle-free hypodermic injection system. The predicate system consists of two (2) injectors; a reset… | 2009 |
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 17 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K081532.
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. 2011, this device’s year, is highlighted.
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?
The PharmaJet® Stratis Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet® Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111517: Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis Reset Stati.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111517
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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