510(k) · Cleared
ClearedRetractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Caina Medical Co.,Ltd · MEG Syringe, Antistick
Cleared on Oct 3, 2019 as substantially equivalent to K980069 (Retractable Technologies, Inc., 1998) and 2 other predicates after a 120-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Oct 3, 2019
- Review
- 120 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000572 (2000). 10 ancestors in all, the oldest K922522 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 3 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 2 generations backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 1 generation backK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- This deviceK191490 Retractable Safety Syringe, Retractable Safety Insulin Syringe…Jiangsu Caina Medical Co.,Ltd · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −3 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −2 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −1 | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray | M.K. Meditech Co., Ltd. | 2003 | — |
| 0 (this device) | K191490 | Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable… | Jiangsu Caina Medical Co.,Ltd | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K980069 | Vanishpoint SyringeSummary page 4…01-3609253199 Email: [email protected] Date of Preparation: 10/3/2019 2. Identification of Predicate Device Predicate Device 1 510(k) Number: K980069 Product Name: Automated Retractable VanishPoint Syringe Predicate Device 2 510(k) Number: K031594 Product N… | 1998 |
| * | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe TraySummary page 4…e Device Predicate Device 1 510(k) Number: K980069 Product Name: Automated Retractable VanishPoint Syringe Predicate Device 2 510(k) Number: K031594 Product Name: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray Predicate Device 3… | 2003 |
| * | K132681 | Sol-Guard Insulin and Tuberculin Safety SyringeSummary page 4…510(k) Number: K031594 Product Name: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray Predicate Device 3 510(k) Number: K132681 Product Name: Sol-Guard Insulin and Tuberculin Safety Syringes 3. Identification of Subject Device Trade Name: Re… | 2014 |
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 19 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K980069.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the…
Read the full statement (241 words)
The Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
For general injection use: The function of Retractable Safety Syringe is to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. The syringe contains various capacity, such as 1ml, 2.5ml, 3ml, 5ml and 10ml.
For allergy use: The 1ml Retractable Safety Allergy Syringe is intended for the preparation/mixing of allergenic extracts/prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
For Tuberculin use: The 1ml Retractable Safety Tuberculin Syringe is intended for the delivery of Tuberculin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191490: Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191490
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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