510(k) · Cleared
ClearedNeomed Oral/Enteral Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neomed, Inc. · FMF Syringe, Piston
Cleared on Sep 20, 2012 as substantially equivalent to K092908 (Neomed, Inc., 2010) after a 45-day review. Its family tree reaches back 2 generations to 1995. 1 of the 39 devices in its family, counting itself, has a Class I recall. 36 later devices descend from it.
- Decided
- Sep 20, 2012
- Review
- 45 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951871 (1995). 36 later devices descend from it, 3 citing it directly. 1 of the 39 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK951871 Piston SyringeBaxa Corp. · 1995
- 1 generation backK092908 Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO…Neomed, Inc. · 2010
- This deviceK122373 Neomed Oral/Enteral SyringeNeomed, Inc. · 2012
- Descendant · cites it directly · 34 of its ownK143344 NeoMed NeoConnect Enteral Syringes with ENFit ConnectorNeomed, Inc. · 2015
- Descendant · 2 generations on · 30 of its ownK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- Descendant · 3 generations on · 21 of its ownK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- Descendant · 4 generations on · 5 of its ownK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK160419 Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien · 2016
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190502 ENFit Oral / Enteral Syringe4 generations on · 2019
Most influential descendants
Showing 5 of 36 · See all- K143344NeoMed NeoConnect Enteral Syringes with ENFit ConnectorNeomed, Inc. · 2015 · cites it directly34descendants
- K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 2015 · 2 generations on30descendants
- K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect…Neomed, Inc. · 2016 · 3 generations on21descendants
- K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Neomed, Inc. · 2019 · 4 generations on5descendants
- K160419Monoject Enteral Feeding Syringe with ENFit ConnectorCovidien · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951871 | Piston Syringe | Baxa Corp. | 1995 | — |
| −1 | K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO… | Neomed, Inc. | 2010 | — |
| 0 (this device) | K122373 | Neomed Oral/Enteral Syringe | Neomed, Inc. | 2012 | — |
| +1 | K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector | Neomed, Inc. | 2015 | — |
| +2 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| +3 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and… | Neomed, Inc. | 2016 | — |
| +4 | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip… | Neomed, Inc. | 2019 | — |
| +3 | K160419 | Monoject Enteral Feeding Syringe with ENFit Connector | Covidien | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K092908 | Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO…Summary page 1…IVALENCE: The principle device of this 510(k) premarket notification is the result of device modification (increase of product family size range) to the predicate device K092908 which were conducted in accordance with Quality System Regulations, 21 CFR 820. The NeoMed Oral I Enteral Syringes ranging from… | 2010 |
What descends from it? (36)
See all 363 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190502ENFit Oral / Enteral SyringeJiangsu Caina Medical Co.,Ltd · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143344 (Neomed, Inc., 2015) has gone furthest, with 34 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. 2012, 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?
The device is indicated for use as a dispenser, a mneasuring device and an oral fluid transfer device. It is used to inject fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122373: Neomed Oral/Enteral Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122373
Report an extraction error
Are you the manufacturer?
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