510(k) · Cleared
ClearedPop-N-Lok Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retractable Technologies, Inc. · MEG Syringe, Antistick
Cleared on Dec 28, 1995 after a 372-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 28, 1995
- Review
- 372 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 5 citing it directly.
- This deviceK946219 Pop-N-Lok SyringeRetractable Technologies, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK060971 Omi Retractable Saftey Syringe, VariousOmi Manufacturing Pty., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK051762 Saf-T-Syringe/Saf-T-NeedleSafety Medical International, Incorporated · 2005
- Descendant · cites it directly · 0 of its ownK032517 Medsafe Clicksafe Safety Antistick Syringe with Hypodermic NeedleMedsafe Technologies, LLC · 2004
- Descendant · cites it directly · 0 of its ownK013006 Ovus Capless Safety NeedleOvus Systems · 2002
- Descendant · cites it directly · 0 of its ownK982431 NMT Safety SyringeNew Medical Technology, Ltd. · 1998
Most influential descendants
Showing 5 of 5 · See all- K060971Omi Retractable Saftey Syringe, VariousOmi Manufacturing Pty., Ltd. · 2006 · cites it directly0descendants
- K051762Saf-T-Syringe/Saf-T-NeedleSafety Medical International, Incorporated · 2005 · cites it directly0descendants
- K032517Medsafe Clicksafe Safety Antistick Syringe with Hypodermic NeedleMedsafe Technologies, LLC · 2004 · cites it directly0descendants
- K013006Ovus Capless Safety NeedleOvus Systems · 2002 · cites it directly0descendants
- K982431NMT Safety SyringeNew Medical Technology, Ltd. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946219 | Pop-N-Lok Syringe | Retractable Technologies, Inc. | 1995 | — |
| +1 | K060971 | Omi Retractable Saftey Syringe, Various | Omi Manufacturing Pty., Ltd. | 2006 | — |
| +1 | K051762 | Saf-T-Syringe/Saf-T-Needle | Safety Medical International, Incorporated | 2005 | — |
| +1 | K032517 | Medsafe Clicksafe Safety Antistick Syringe with Hypodermic Needle | Medsafe Technologies, LLC | 2004 | — |
| +1 | K013006 | Ovus Capless Safety Needle | Ovus Systems | 2002 | — |
| +1 | K982431 | NMT Safety Syringe | New Medical Technology, Ltd. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
5 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, K060971 (Omi Manufacturing Pty., Ltd., 2006) has gone furthest, with 0 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 | — |
https://510kreport.com/device/K946219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946219: Pop-N-Lok Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946219
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026