Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PNR — Predicate Candidate Screening
34 FDA 510(k) clearances under this product code; the 50 most recent screened below.
158 daysmedian FDA review time
282 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252483 | Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. | 2026-07-01 | 328 | 0 |
| K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable E | CMT Health PTE., Ltd. | 2026-04-08 | 191 | 0 |
| K251585 | Profoject™ Enteral Feeding Syringe | CMT Health PTE., Ltd. | 2025-07-18 | 56 | 0 |
| K243652 | Monoject™ Enteral Syringe with ENFit Connector (401SE); Mono | Cardinalhealth | 2024-12-19 | 23 | 0 |
| K231300 | Nutricair Enteral Syringe with ENFit | Cair Lgl | 2023-10-06 | 155 | 0 |
| K222772 | Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 | 337 | 0 |
| K211661 | ENFit enteral syringes (NUTRIFIT) | Pentaferte Italia S.R.L. | 2022-02-28 | 272 | 0 |
| K211593 | Enteral Pump Syringe | Jiangsu Caina Medical Co.,Ltd | 2021-09-30 | 129 | 0 |
| K203613 | ENFit Reusable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2021-08-27 | 260 | 0 |
| K211025 | Oral/Enteral Syringe with ENFit connector | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-06-30 | 85 | 0 |
| K203410 | ENFit Disposable Enteral Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2021-06-28 | 221 | 0 |
| K210621 | Oral/Enteral Syringe | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-04-28 | 57 | 0 |
| K202285 | Medline ENfit OTC Feeding Syringe | Medline Industries, Inc. | 2020-10-09 | 58 | 0 |
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; | Jiangsu Shenli Medical Production Co., Ltd. | 2020-09-28 | 209 | 0 |
| K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | Shinva Ande Healthcare Apparatus Co., Ltd. | 2020-09-12 | 257 | 0 |
| K190502 | ENFit Oral / Enteral Syringe | Jiangsu Caina Medical Co.,Ltd | 2019-08-06 | 158 | 4 |
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), | Neomed, Inc. | 2019-04-30 | 131 | 0 |
| K182649 | Enteral Feeding Syringes with Enfit Connectors | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2018-11-09 | 46 | 0 |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/ | Jiangsu Micsafe Medical Technology Co., Ltd. | 2018-10-11 | 133 | 0 |
| K171857 | AMSure® Enteral Feeding Syringe with ENFit Tip | Amsino International, Inc. | 2018-03-30 | 282 | 0 |
| K170371 | DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 | Intervene Group Limited | 2017-10-20 | 256 | 0 |
| K170672 | Tamper Evident Cap For use with ENFit Syringes | International Medical Industries, Inc. | 2017-10-06 | 214 | 0 |
| K161979 | ENFit enteral syringe | Jiangyin Caina Technology Co., Ltd. | 2017-03-22 | 247 | 0 |
| K161141 | ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump | Pentaferte Italia S.R.L. | 2017-03-22 | 334 | 0 |
| K161811 | Medela Low Dose Enteral Syringe | Medela, Inc. | 2017-02-15 | 229 | 0 |
| K160855 | U&U Enteral Syringe | U&U Medical Technology Co, Ltd. | 2016-11-22 | 239 | 0 |
| K162188 | Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enter | Vr Medical Technology | 2016-09-22 | 49 | 0 |
| K161963 | Monoject Enteral Syringe with ENFit Connector | Covidien | 2016-09-01 | 45 | 0 |
| K161045 | Monoject | Covidien | 2016-06-17 | 65 | 0 |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL | Neomed, Inc. | 2016-06-17 | 65 | 0 |
| K160419 | Monoject Enteral Feeding Syringe with ENFit Connector | Covidien | 2016-05-12 | 86 | 0 |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and | Neomed, Inc. | 2015-12-17 | 78 | 0 |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector | Neomed, Inc. | 2015-04-09 | 139 | 0 |
| K142128 | KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR | Covidien | 2015-02-23 | 203 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda