510(k) · Cleared
ClearedGettig Disposable Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gettig Pharmaceutical Instrument Co. · FMF Syringe, Piston
Cleared on Oct 8, 2002 as substantially equivalent to K941562 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Oct 8, 2002
- Review
- 71 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771205 (1977). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −1 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| 0 (this device) | K022495 | Gettig Disposable Syringes | Gettig Pharmaceutical Instrument Co. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 FMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K941562 | 1ML Luer-Lok SyringeSummary page 1…e: Gettig Disposable Syringe Common Name: Piston Syringe Classification Name: Piston Syringe 3. Predicate Device Information: A. Becton Dickinson Syringe (K#941562) 6. Terumo Disposable Syringe (K#980181) 4. Device Description: The Gettig Disposable Syringe is a standard piston syri… | 1994 |
| * | K980181 | Terumo Disposable Hypodermc SyringeSummary page 1…e: Piston Syringe Classification Name: Piston Syringe 3. Predicate Device Information: A. Becton Dickinson Syringe (K#941562) 6. Terumo Disposable Syringe (K#980181) 4. Device Description: The Gettig Disposable Syringe is a standard piston syringe. It consists of a calibrated hollow… | 1998 |
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 25 years and passes through 3 companies; a new generation was cleared every 20.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K941562.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Gettig Disposable Syringe, with or without a hypodermic single lumen needle, is used for injecting fluids into or withdrawing fluids from the body. The syringe is designed for manual use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022495 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022495: Gettig Disposable Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022495
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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