510(k) · Cleared
ClearedMedline Retractable Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · MEG Syringe, Antistick
Cleared on Mar 25, 2011 as substantially equivalent to K032780 (Inviro Medical, 2003) and 1 other predicate after a 294-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Mar 25, 2011
- Review
- 294 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K941450 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK941450 Inviro SyringeDr. F. Ross Sharp, Ltd. · 1994
- 2 generations backK032780 Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical · 2003
- 1 generation backK092430 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock…Inviro Medical Devices, Inc. · 2009
- This deviceK101560 Medline Retractable Safety SyringeMedline Industries, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941450 | Inviro Syringe | Dr. F. Ross Sharp, Ltd. | 1994 | — |
| −2 | K032780 | Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CC | Inviro Medical | 2003 | — |
| −1 | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML… | Inviro Medical Devices, Inc. | 2009 | — |
| 0 (this device) | K101560 | Medline Retractable Safety Syringe | Medline Industries, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K032780 | Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCSummary page 1…Safety Syringe Common Name: Piston or Safety Syringe Predicate Information Predicate Name: Inviro Snap Safety Syringe / InviroSnap Safety Syringe Predicate 5 10(k) #: K032780 / K092430 Predicate Product Code: MEG Device Description The Medline Retractable Safety Syringe is a retractable type piston sy… | 2003 |
| * | K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…Summary page 1…ringe Common Name: Piston or Safety Syringe Predicate Information Predicate Name: Inviro Snap Safety Syringe / InviroSnap Safety Syringe Predicate 5 10(k) #: K032780 / K092430 Predicate Product Code: MEG Device Description The Medline Retractable Safety Syringe is a retractable type piston syringe, des… | 2009 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K032780.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 Medline Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, this safety syringe is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101560: Medline Retractable 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/K101560
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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