510(k) · Cleared
ClearedProsafe Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hou-Se Medical, Inc. · MEG Syringe, Antistick
Cleared on Oct 18, 2001 after a 64-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Oct 18, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK012726 Prosafe Safety SyringeHou-Se Medical, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK052397 Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Life-Shield Products, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK060208 Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK061055 Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006
- Descendant · 4 generations on · 0 of its ownK072037 Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK031830 Safepro Plus Safety SyringeFormosa Medical Devices, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K052397Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Life-Shield Products, Inc. · 2005 · cites it directly3descendants
- K060208Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006 · 2 generations on2descendants
- K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006 · 3 generations on1descendant
- K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007 · 4 generations on0descendants
- K031830Safepro Plus Safety SyringeFormosa Medical Devices, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012726 | Prosafe Safety Syringe | Hou-Se Medical, Inc. | 2001 | — |
| +1 | K052397 | Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML) | Life-Shield Products, Inc. | 2005 | — |
| +2 | K060208 | Careo Safety Syringe 1CC/ML, Models… | Life-Shield Products, Inc. | 2006 | — |
| +3 | K061055 | Careo Safety Syringe for U-100 Insulin | Life-Shield Products, Inc. | 2006 | — |
| +4 | K072037 | Careo Safety Syringe for U-100 Insulin 0.5CC/ML | Life-Shield Products, Inc. | 2007 | — |
| +1 | K031830 | Safepro Plus Safety Syringe | Formosa Medical Devices, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | — | B-D Luer Lok syringe Named without a submission number | |
| * | — | Retractable Technology, Inc. VanishPoint syringe Named without a submission number |
What descends from it? (5)
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, K052397 (Life-Shield Products, Inc., 2005) has gone furthest, with 3 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?
A properly placed syringe provides access to a vein or tissue for fluid sampling or infusion. The safety syringe is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a needle retraction system which is activated after the infusion procedure is completed.
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/K012726 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012726: Prosafe Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012726
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026