510(k) · Cleared
ClearedProfoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CMT Health PTE., Ltd. · PNR Enteral Syringes With Enteral Specific Connectors
Cleared on Apr 8, 2026 as substantially equivalent to K183540 (Neomed, Inc., 2019) and 2 other predicates after a 191-day review. Its family tree reaches back 9 generations to 1980.
- Decided
- Apr 8, 2026
- Review
- 191 days
- Class
- Class II
- Product code
- PNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K801558 (1980). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 5 generations between
- 3 generations backK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- 2 generations backK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- 1 generation backK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
- This deviceK253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable…CMT Health PTE., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK801558 Enteric Feeding Tube W/Segm. Flex. WT.Biosearch Medical Products, Inc. · 1980
- 8 generations backK973409 Kangaroo Enteral Feeding Extension Set for Syringe PumpsDavis & Geck, Inc. · 1998
- 7 generations backK082654 Enteral Only Extension SetRespironics, Inc. · 2008
- 6 generations backK100099 Oral/Enteral SyringesPhilips Children'S Medical Ventures · 2010
- 5 generations backK112434 BD Oral/Enteral Syringe with BD Univia ConnectionBd Medical Surgical · 2011
- 4 generations backK142128 Kangaroo Enteral Feeding Syringes with Enfit ConnectorCovidien · 2015
- 3 generations backK152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and…Neomed, Inc. · 2015
- 2 generations backK161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100…Neomed, Inc. · 2016
- 1 generation backK183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low…Neomed, Inc. · 2019
- This deviceK253268 Profoject Enteral/Oral Feeding Syringe; Profoject Reusable…CMT Health PTE., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801558 | Enteric Feeding Tube W/Segm. Flex. WT. | Biosearch Medical Products, Inc. | 1980 | — |
| −8 | K973409 | Kangaroo Enteral Feeding Extension Set for Syringe Pumps | Davis & Geck, Inc. | 1998 | — |
| −7 | K082654 | Enteral Only Extension Set | Respironics, Inc. | 2008 | — |
| −6 | K100099 | Oral/Enteral Syringes | Philips Children'S Medical Ventures | 2010 | — |
| −5 | K112434 | BD Oral/Enteral Syringe with BD Univia Connection | Bd Medical Surgical | 2011 | — |
| −4 | K142128 | Kangaroo Enteral Feeding Syringes with Enfit Connector | Covidien | 2015 | — |
| −3 | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible… | Neomed, Inc. | 2015 | — |
| −2 | K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and… | Neomed, Inc. | 2016 | — |
| −1 | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip… | Neomed, Inc. | 2019 | — |
| 0 (this device) | K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral… | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 PNR? 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 PNR device
- #1 K252483 Enteral Syringe (20ml, 60ml)score 14.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral…Summary page 7…2 K253268 - page 3/12 3. Predicate Device Identification K183540 - Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6… | 2019 |
| * | K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…Summary page 7…icate Device Identification K183540 - Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) K140581 - Cedic Enteral Distal End ENFit Transition Connector, Cedic Enteral ENFit Transition Connector for Medication Port K152857 - Neo… | 2014 |
| * | K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsSummary page 7…Syringes with ENFit connector (1 mL to 6 mL) K140581 - Cedic Enteral Distal End ENFit Transition Connector, Cedic Enteral ENFit Transition Connector for Medication Port K152857 - NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps 4. Non-Clinical Test Conclusion Non-… | 2015 |
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 46 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 28 ancestors have a recall of any class.
- 3 other devices also cite its predicate K183540.
How does its category compare?
All PNR devicesPNR Enteral Syringes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PNR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNR
129in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNR
4in 2023
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · PNR
7in 2025
MAUDE reports naming product code PNR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 3 | 139 | 0 | 0 |
| 2016 | 6 | 65 | 0 | 1 |
| 2017 | 5 | 247 | 0 | 3 |
| 2018 | 3 | 133 | 0 | 2 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 3 | 209 | 0 | 3 |
| 2021 | 5 | 129 | 0 | 5 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 2 | — | 4 (4) | 11 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Profoject™ Enteral/ Oral Feeding Syringe: The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or non-clinical settings by users ranging from clinicians to laypersons in all age groups. Profoject™ Reusable Enteral/ Oral Feeding Syringe: The device is intended for use as a dispenser, a…
Read the full statement (183 words)
Profoject™ Enteral/ Oral Feeding Syringe:
The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or non-clinical settings by users ranging from clinicians to laypersons in all age groups.
Profoject™ Reusable Enteral/ Oral Feeding Syringe:
The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in clinical and non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
Profoject™ ENFit Adaptor:
The Profoject™ ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
Profoject™ Enteral Feeding Syringes Cap:
The Profoject™ Enteral Feeding Syringes Cap is used to prevent fluid loss and contamination of syringe contents until ready for use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253268: Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253268
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