510(k) · Cleared
ClearedInsosafe Bak'snap Retractable Insulin Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.K. Meditech Co., Ltd. · MEG Syringe, Antistick
Cleared on Apr 5, 2005 as substantially equivalent to K031594 (M.K. Meditech Co., Ltd., 2003) and 2 other predicates after a 74-day review. Its family tree reaches back 4 generations to 2000. 8 later devices descend from it.
- Decided
- Apr 5, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000572 (2000). 12 ancestors in all, the oldest K941657 (1994). 8 later devices descend from it, 3 citing it directly.
- 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 deviceK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- Descendant · cites it directly · 5 of its ownK152808 U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK202570 Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK220061 Safety Insulin SyringesBerpu Medical Technology Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK230061 Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK191639 TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd. · 2016 · cites it directly5descendants
- K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd. · 2021 · 2 generations on2descendants
- K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · 2023 · 4 generations on0descendants
- K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd. · 2020 · 2 generations on0descendants
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) | K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | M.K. Meditech Co., Ltd. | 2005 | — |
| +1 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016 | — |
| +2 | K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021 | — |
| +3 | K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | 2022 | — |
| +4 | K230061 | Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023 | — |
| +2 | K191639 | TK Insulin Syringe with/without Saftey Retractable Device | Anhui Tiankang Medical Technology Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe TraySummary page 1…on Name: Piston syringe Hypodermic single lumen needle 3. PREDICATE DEVICES * I mL Bak'SNAPTM DuoProSSTM (K031594) * Inviro Snap Safety Syringe (K040036) * BD Safety-Glide (K992734) 4. DEVICE DESCRIPTION The… | 2003 |
| * | K040036 | Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Summary page 1…Hypodermic single lumen needle 3. PREDICATE DEVICES * I mL Bak'SNAPTM DuoProSSTM (K031594) * Inviro Snap Safety Syringe (K040036) * BD Safety-Glide (K992734) 4. DEVICE DESCRIPTION The InsoSAFETM Bak'SNAPTM Retractable Insulin Safety… | 2004 |
| * | K992734 | Becton Dickinson SyringeSummary page 1…en needle 3. PREDICATE DEVICES * I mL Bak'SNAPTM DuoProSSTM (K031594) * Inviro Snap Safety Syringe (K040036) * BD Safety-Glide (K992734) 4. DEVICE DESCRIPTION The InsoSAFETM Bak'SNAPTM Retractable Insulin Safety Syringe is a sterile, single- us… | 1999 |
What descends from it? (8)
3 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K152808 (U&U Medical Technology Co, Ltd., 2016) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K031594.
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 InsoSAFE Bak'SNAP Retractable Insulin Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050131: Insosafe Bak'snap Retractable Insulin 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/K050131
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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