510(k) · Cleared
Recalled · 2012Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · FMF Syringe, Piston
Cleared on Nov 25, 1992 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 25, 1992
- Review
- 181 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 4
- Predicates
- 0
29 later devices descend from it, 5 citing it directly.
- This deviceK922522 Monoject Safety Syringe, 1 CC, 3CC and 12 CC SizesSherwood Medical Co. · 1992
- Descendant · cites it directly · 20 of its ownK061492 Monoject Magellan Insulin and Tuberculin Safety SyringeTyco Healthcare · 2006
- Descendant · 2 generations on · 16 of its ownK132681 Sol-Guard Insulin and Tuberculin Safety SyringeSol-Millennium Medical, Inc. · 2014
- Descendant · 3 generations on · 14 of its ownK192551 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently…Jiangsu Caina Medical Co.,Ltd · 2020
- Descendant · 4 generations on · 6 of its ownK210443 PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK080600 Ultimed Ulticare Safety SyringeUltimed, Inc. · 2008
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K061492Monoject Magellan Insulin and Tuberculin Safety SyringeTyco Healthcare · 2006 · cites it directly20descendants
- K132681Sol-Guard Insulin and Tuberculin Safety SyringeSol-Millennium Medical, Inc. · 2014 · 2 generations on16descendants
- K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd · 2020 · 3 generations on14descendants
- K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. · 2021 · 4 generations on6descendants
- K080600Ultimed Ulticare Safety SyringeUltimed, Inc. · 2008 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922522 | Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes | Sherwood Medical Co. | 1992 | — |
| +1 | K061492 | Monoject Magellan Insulin and Tuberculin Safety Syringe | Tyco Healthcare | 2006 | — |
| +2 | K132681 | Sol-Guard Insulin and Tuberculin Safety Syringe | Sol-Millennium Medical, Inc. | 2014 | — |
| +3 | K192551 | 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| +4 | K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021 | — |
| +1 | K080600 | Ultimed Ulticare Safety Syringe | Ultimed, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 295 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2012 | Not classified | Z-1696-2012 | Equipment maintenance | Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick |
| May 21, 2012 | Not classified | Z-1694-2012 | Equipment maintenance | Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick |
| May 21, 2012 | Not classified | Z-1695-2012 | Equipment maintenance | Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick |
| May 21, 2012 | Not classified | Z-1697-2012 | Equipment maintenance | Safety shield may separate from the syringe, exposing the needle, which could potentially result in a needle stick |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061492 (Tyco Healthcare, 2006) has gone furthest, with 20 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K922522 · printed Nov 5, 2026
Cite this page
510(k) Report. “K922522: Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922522
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026