510(k) · Cleared
ClearedSaf-T-Syringe/Saf-T-Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safety Medical International, Incorporated · MEG Syringe, Antistick
Cleared on Sep 23, 2005 as substantially equivalent to K946219 (Retractable Technologies, Inc., 1995) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 23, 2005
- Review
- 85 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946219 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK946219 Pop-N-Lok SyringeRetractable Technologies, Inc. · 1995
- This deviceK051762 Saf-T-Syringe/Saf-T-NeedleSafety Medical International, Incorporated · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946219 | Pop-N-Lok Syringe | Retractable Technologies, Inc. | 1995 | — |
| 0 (this device) | K051762 | Saf-T-Syringe/Saf-T-Needle | Safety Medical International, Incorporated | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 MEG? 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 MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 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 |
|---|---|---|---|
| * | K946219 | Pop-N-Lok SyringeSummary page 1…Equivalency is claimed against the following devices: POP-N-LOCK SYRINGE ( currently marketed as the VANISHPOINI TM SYRINGE) from RETRACTABLE TECHNOLOGIES, INC., 510Ok #k946219, BD INTEGRA TM Syringe, from BECTON DICKINSON MEDICAL SURGICAL, 51 0(k) #k01 1103. 11. Description of the Device: The Saf-I-Syri… | 1995 |
| * | K011103 | BD Spring Based SyringeSummary page 1…ntly marketed as the VANISHPOINI TM SYRINGE) from RETRACTABLE TECHNOLOGIES, INC., 510Ok #k946219, BD INTEGRA TM Syringe, from BECTON DICKINSON MEDICAL SURGICAL, 51 0(k) #k01 1103. 11. Description of the Device: The Saf-I-Syringe is a 3cc, 5cc, and 10cc, sterile, non-toxic, non-pyrogenlc, disposable, one-ha… | 2001 |
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 2 ancestors has a recall.
- 4 other devices also cite its predicate K946219.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Saf-T-Syringe's primary intended use is to provide a safe, accurate and reliable method of injecting medication into a patient. The syringe is available in a 3cc, 5cc and 10cc with various needle sizes. The needle automatically withdraws and prevents accidental needle sticks.
3cc, 5cc, and 10cc Syringes are available for:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051762: Saf-T-Syringe/Saf-T-Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051762
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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