510(k) · Cleared
Recalled · Class II · 2021Monoject Safety Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare · FMI Needle, Hypodermic, Single Lumen
Cleared on Oct 25, 2001 as substantially equivalent to K951254 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1995) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it. It has been recalled 93 times.
- Decided
- Oct 25, 2001
- Review
- 70 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 93
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911037 (1991). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK911037 Safety Needle Sheath, ModificationConcord/Portex · 1991
- This deviceK012736 Monoject Safety NeedleTyco Healthcare · 2001
- Descendant · cites it directly · 0 of its ownK253110 Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK082908 Novaguard, Model 3611001West Pharmaceutical Services, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911037 | Safety Needle Sheath, Modification | Concord/Portex | 1991 | — |
| 0 (this device) | K012736 | Monoject Safety Needle | Tyco Healthcare | 2001 | — |
| +1 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026 | — |
| +1 | K082908 | Novaguard, Model 3611001 | West Pharmaceutical Services, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2026 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K951254 | Safetyglide NeedleSummary page 1…vice The proposed Kendall Monoject® Safety Needle is substantially equivalent in intended use, design and function to Becton Dickinson’s SafetyGlide™ Needle, 510(k) No. K951254 and the Concord/Portex (Sims) Needle-Pro®, 510(k) No. K911037. Device Description The proposed device consists of a sterile, si… | 1995 |
| * | K911037 | Safety Needle Sheath, ModificationSummary page 1…ially equivalent in intended use, design and function to Becton Dickinson’s SafetyGlide™ Needle, 510(k) No. K951254 and the Concord/Portex (Sims) Needle-Pro®, 510(k) No. K911037. Device Description The proposed device consists of a sterile, single-lumen hypodermic needle with an attached safety shield. T… | 1991 |
What descends from it? (2)
2 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 9, 2021 | Class II | Z-1252-2021 | Equipment maintenance | Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens |
| Oct 26, 2007 | Not classified | Z-0730-2008 | Mixed-up of materials/components | Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21 needle specified on the kit label. |
| Oct 26, 2007 | Not classified | Z-0729-2008 | Mixed-up of materials/components | Incorrect Needle size - Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label. |
| Oct 8, 2004 | Not classified | Z-0151-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0138-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0092-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0100-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0080-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0107-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0073-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0095-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0134-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0076-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0143-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0097-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0070-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0101-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0090-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0079-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0094-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0111-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0084-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0112-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0117-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0113-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0121-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0132-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0071-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0136-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0091-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0140-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0081-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0145-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0077-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0066-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0098-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0072-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0099-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0085-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0104-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0069-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0068-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0075-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0110-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0064-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0123-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0125-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0106-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0065-05 | Other | Needle cannula may separate from the hub during use |
| Oct 8, 2004 | Not classified | Z-0074-05 | Other | Needle cannula may separate from the hub during use |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The primary function of the device is to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The needle stick prevention feature of the device helps prevent accidental needle sticks by shielding the needle after use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012736: Monoject Safety Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012736
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026