510(k) · Cleared
ClearedCareo Safety Syringe for U-100 Insulin 0.5CC/ML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life-Shield Products, Inc. · MEG Syringe, Antistick
Cleared on Aug 8, 2007 as substantially equivalent to K050131 (M.K. Meditech Co., Ltd., 2005) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Aug 8, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000572 (2000). 21 ancestors in all, the oldest K941657 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK000572 E.N.S.I. SyringeTri-Ject Intl. Corp. · 2000
- 4 generations backK020623 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 3 generations backK022806 Duopro Safety Syringe (Duopross)M.K. Meditech Co., Ltd. · 2002
- 2 generations backK031594 Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety…M.K. Meditech Co., Ltd. · 2003
- 1 generation backK050131 Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd. · 2005
- This deviceK072037 Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000572 | E.N.S.I. Syringe | Tri-Ject Intl. Corp. | 2000 | — |
| −4 | K020623 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −3 | K022806 | Duopro Safety Syringe (Duopross) | M.K. Meditech Co., Ltd. | 2002 | — |
| −2 | K031594 | Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray | M.K. Meditech Co., Ltd. | 2003 | — |
| −1 | K050131 | Insosafe Bak'snap Retractable Insulin Safety Syringe | M.K. Meditech Co., Ltd. | 2005 | — |
| 0 (this device) | K072037 | Careo Safety Syringe for U-100 Insulin 0.5CC/ML | Life-Shield Products, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K050131 | Insosafe Bak'snap Retractable Insulin Safety SyringeSummary page 1…MEG Classification Name: Syringe, Antistick 3. Predicate Device * [nsoSAFE M Bak'SNAPTM Retractable Insulin Safety Syringe (K050131) * CAREO Safety Syringe for 1-100 Insulin (K061055) 4. Device Description The Life-Shield Products,… | 2005 |
| * | K061055 | Careo Safety Syringe for U-100 InsulinSummary page 1…tistick 3. Predicate Device * [nsoSAFE M Bak'SNAPTM Retractable Insulin Safety Syringe (K050131) * CAREO Safety Syringe for 1-100 Insulin (K061055) 4. Device Description The Life-Shield Products, Inc., CAREO Safety Syringe for 1J-100 Insulin 0.5cc/mL is a… | 2006 |
| † | K030976 | Careo Retractable Safety Syringe | 2003 |
| † | K052397 | Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML) | 2005 |
| † | K060208 | Careo Safety Syringe 1CC/ML, Models… | 2006 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 21 ancestors have a recall of any class.
- 2 other devices also cite its predicate K050131.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient.
The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072037 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072037: Careo Safety Syringe for U-100 Insulin 0.5CC/ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072037
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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