510(k) · Cleared
ClearedSaviSafe Safety Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Savicred Biotechnology Co., Ltd. · MEG Syringe, Antistick
Cleared on Nov 21, 2023 as substantially equivalent to K123743 (Safety Syringes, Inc., 2013) after a 292-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Nov 21, 2023
- Review
- 292 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011369 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK011369 Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory)Safety Syringes, Inc. · 2001
- 2 generations backK122558 Ultrasafe Passive Needle GuardSafety Syringes, Inc. · 2012
- 1 generation backK123743 Ultrasafe Plus Passive Needle GuardSafety Syringes, Inc. · 2013
- This deviceK230287 SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011369 | Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory) | Safety Syringes, Inc. | 2001 | — |
| −2 | K122558 | Ultrasafe Passive Needle Guard | Safety Syringes, Inc. | 2012 | — |
| −1 | K123743 | Ultrasafe Plus Passive Needle Guard | Safety Syringes, Inc. | 2013 | — |
| 0 (this device) | K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K123743 | Ultrasafe Plus Passive Needle GuardSummary page 5…Name: Piston syringe Regulatory Class: II Product Code: MEG IV. Identification of Predicate Device [807.92(a)(3)] Name of Device: UltraSafe Passive PLUS Needle Guard (K123743) Regulation Number: 21 CFR 880.5860 Common Name: Syringe, Antistick Classification Name: Piston syringe Regulatory Class: II Prod… | 2013 |
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 22 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K123743.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Savisafe Safety Device is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230287: SaviSafe Safety Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230287
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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