510(k) · Cleared
ClearedGettig Styrl-Ject Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gettig Pharmaceutical Instrument Co. · EJI Syringe, Cartridge
Cleared on Sep 11, 1997 as substantially equivalent to K851903 (Astra Pharmaceutical Products, Inc., 1985) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Sep 11, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K771205 (1977). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- This deviceK972285 Gettig Styrl-Ject Delivery SystemGettig Pharmaceutical Instrument Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| 0 (this device) | K972285 | Gettig Styrl-Ject Delivery System | Gettig Pharmaceutical Instrument Co. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 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 EJI? 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? (4)
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 |
|---|---|---|---|
| * | K851903 | Astra Lightweight Stainless Steel Self Aspir/SyrinSummary page 1…devices currently and previously marketed having the same intended use for medicament administration. The device has attributes similar to the Astra Aspirating Syringe (K851903), the Terumo Hypodermic Syringe (K771205), the Wyeth Tubex® (Pre-amendment), and the Monoject® Prefilled Syringe (K812934). ===… | 1985 |
| * | K771205 | Hypodermic SyringeSummary page 1…d having the same intended use for medicament administration. The device has attributes similar to the Astra Aspirating Syringe (K851903), the Terumo Hypodermic Syringe (K771205), the Wyeth Tubex® (Pre-amendment), and the Monoject® Prefilled Syringe (K812934). Device Description The Gettig… | 1977 |
| * | K812934 | Monoject Prefilled SyringesSummary page 1…ibutes similar to the Astra Aspirating Syringe (K851903), the Terumo Hypodermic Syringe (K771205), the Wyeth Tubex® (Pre-amendment), and the Monoject® Prefilled Syringe (K812934). Device Description The Gettig Styrl-Ject® Delivery System is a sterile, single use hypodermic syringe cartridg… | 1981 |
| * | — | Wyeth Tubex 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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K851903.
How does its category compare?
All EJI devicesEJI Syringe, Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · EJI
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EJI
No recall names EJI since 2007.
Adverse event reports per year · EJI
1in 2025
MAUDE reports naming product code EJI, 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 | 1 | — | 0 | 2 |
| 2009 | 3 | 78 | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indications for use of the device is to inject medicaments subcutaneously, intramuscularly, or via I.V. access ports. This device is intended for all adult patient populations based upon the appropriate needle size selection by the physician or clinician, and is governed by the specific drug being administered. Any pediatric applications is at the discretion of the physician and governed by the specific drug being administered.
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/K972285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972285: Gettig Styrl-Ject Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972285
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