510(k) · Cleared
ClearedRevital Cady
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Revital Healthcare (Epz) Limited · FMF Syringe, Piston
Cleared on Nov 6, 2023 as substantially equivalent to K210464 (Anhui Tiankang Medical Technology Co., Ltd., 2021) and 1 other predicate after a 165-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Nov 6, 2023
- Review
- 165 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K904198 (1990). 37 ancestors in all, the oldest K771205 (1977). No later device cites it as a predicate yet.
- Root · 8 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 7 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 6 generations backK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- 5 generations backK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- 4 generations backK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- 3 generations backK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- 2 generations backK180417 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic…Berpu Medical Technology Co., Ltd. · 2018
- 1 generation backK211214 Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc. · 2021
- This deviceK231519 Revital CadyRevital Healthcare (Epz) Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −7 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −6 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| −5 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| −4 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| −3 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| −2 | K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes… | Berpu Medical Technology Co., Ltd. | 2018 | — |
| −1 | K211214 | Sterile Hypodermic Needles for Single Use | Azur Medical Company, Inc. | 2021 | — |
| 0 (this device) | K231519 | Revital Cady | Revital Healthcare (Epz) Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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 |
|---|---|---|---|
| * | K210464 | Auto Disable SyringeSummary page 6…ice 510K Predicate Device510K Revital Auto Disable Syringe with K210464 K211214 Healthcare (EPZ) Needle for Fixed Dose (For Needle) Limited… | 2021 |
| * | K211214 | Sterile Hypodermic Needles for Single UseSummary page 6…dicate Device510K Revital Auto Disable Syringe with K210464 K211214 Healthcare (EPZ) Needle for Fixed Dose (For Needle) Limited Immunization 6. D… | 2021 |
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 33 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 6 of the 37 ancestors have a recall of any class.
- 1 other device also cites its predicate K210464.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
Auto-Disable Syringe is used to administer intramuscular / intravenous medicines or fixed dose immunization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231519: Revital Cady.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231519
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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