510(k) · Cleared
ClearedSafepro Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Formosa Medical Devices, Inc. · MEG Syringe, Antistick
Cleared on Aug 29, 2002 after a 65-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Aug 29, 2002
- Review
- 65 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK022063 Safepro Safety SyringeFormosa Medical Devices, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK050134 Icc Insulin Safepro Safety SyringeFormosa Medical Devices, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK080877 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited · 2008
- Descendant · cites it directly · 2 of its ownK060208 Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK093400 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited · 2010
- Descendant · 2 generations on · 1 of its ownK061055 Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K050134Icc Insulin Safepro Safety SyringeFormosa Medical Devices, Inc. · 2005 · cites it directly6descendants
- K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited · 2008 · 2 generations on2descendants
- K060208Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006 · cites it directly2descendants
- K0934001ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited · 2010 · 3 generations on1descendant
- K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022063 | Safepro Safety Syringe | Formosa Medical Devices, Inc. | 2002 | — |
| +1 | K050134 | Icc Insulin Safepro Safety Syringe | Formosa Medical Devices, Inc. | 2005 | — |
| +2 | K080877 | 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2 | Unilife Medical Solutions Limited | 2008 | — |
| +1 | K060208 | Careo Safety Syringe 1CC/ML, Models… | Life-Shield Products, Inc. | 2006 | — |
| +3 | K093400 | 1ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2 | Unilife Medical Solutions Limited | 2010 | — |
| +2 | K061055 | Careo Safety Syringe for U-100 Insulin | Life-Shield Products, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | — | B-D Luer Lok syringe Named without a submission number | |
| * | — | Retractable Technology, Inc. VanishPoint Named without a submission number | |
| * | — | SafePro Safety Syringe Named without a submission number |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K050134 (Formosa Medical Devices, Inc., 2005) has gone furthest, with 6 descendants of its own.
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 primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid.
The secondary indicated use for the 1cc SafePro* Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022063: Safepro Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022063
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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