510(k) · Cleared
Recalled · Class II · 2026Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee
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 Apr 12, 1985 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 12, 1985
- Review
- 25 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK851090 Monoject Sterile 1/2 CC & 1CC Syringes W & W/O NeeSherwood Medical Co. · 1985
- Descendant · cites it directly · 3 of its ownK991758 Monoject Insulin SyringeThe Kendal Co. · 1999
- Descendant · cites it directly · 0 of its ownK180683 Certa Dose Pediatric Midazolam 5mg/mL IM SyringeCerta Dose, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK160589 Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK081547 Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK033373 Monoject Insulin SyringeTyco Healthcare · 2003 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K991758Monoject Insulin SyringeThe Kendal Co. · 1999 · cites it directly3descendants
- K180683Certa Dose Pediatric Midazolam 5mg/mL IM SyringeCerta Dose, Inc. · 2018 · cites it directly0descendants
- K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc. · 2017 · 2 generations on0descendants
- K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc. · 2008 · cites it directly0descendants
- K033373Monoject Insulin SyringeTyco Healthcare · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851090 | Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee | Sherwood Medical Co. | 1985 | — |
| +1 | K991758 | Monoject Insulin Syringe | The Kendal Co. | 1999 | — |
| +1 | K180683 | Certa Dose Pediatric Midazolam 5mg/mL IM Syringe | Certa Dose, Inc. | 2018 | — |
| +2 | K160589 | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe | Certa Dose, Inc. | 2017 | — |
| +1 | K081547 | Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CC | Bio-Med USA, Inc. | 2008 | — |
| +2 | K033373 | Monoject Insulin Syringe | Tyco Healthcare | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 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? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2026 | Class II | Z-1768-2026 | Under Investigation by firm | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991758 (The Kendal Co., 1999) has gone furthest, with 3 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/K851090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K851090: Monoject Sterile 1/2 CC & 1CC Syringes W & W/O Nee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851090
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026