FDA product code PNR: Enteral Syringes With Enteral Specific Connectors
PNR is the FDA product code for enteral syringes with enteral specific connectors. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 34 510(k) submissions under PNR, 7 in the last five years, from 23 different applicants. The average 510(k) review took 166 days (median 156); 113 days on average over the last three years. FDA has posted 4 recalls for PNR devices, 4 initiated in the last five years.
Definition
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
Classification
| Field | Value |
|---|---|
| Device name | Enteral Syringes With Enteral Specific Connectors |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PNR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 256 |
| 2018 | 3 | 154 |
| 2019 | 2 | 144 |
| 2020 | 3 | 175 |
| 2021 | 5 | 150 |
| 2022 | 1 | 272 |
| 2023 | 2 | 246 |
| 2024 | 1 | 23 |
| 2025 | 1 | 56 |
| 2026 | 2 | 260 |
Compare with all 510(k) review times · Search every PNR clearance
Top PNR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neomed, Inc. | 4 | 2019-04-30 |
| Covidien | 4 | 2016-09-01 |
| CMT Health PTE., Ltd. | 2 | 2026-04-08 |
| Pentaferte Italia S.R.L. | 2 | 2022-02-28 |
| Jiangsu Caina Medical Co.,Ltd | 2 | 2021-09-30 |
18 more applicants have PNR clearances. See the full list in Caduvo.
Most recent PNR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252483 | Chirana T.Injecta,A.S. | Enteral Syringe (20ml, 60ml) | 2026-07-01 | 328 |
| K253268 | CMT Health PTE., Ltd. | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | 2026-04-08 | 191 |
| K251585 | CMT Health PTE., Ltd. | Profoject Enteral Feeding Syringe | 2025-07-18 | 56 |
| K243652 | Cardinalhealth | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE) | 2024-12-19 | 23 |
| K231300 | Cair Lgl | Nutricair Enteral Syringe with ENFit | 2023-10-06 | 155 |
Recalls for PNR devices
4 product recalls in 1 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-12-28.
| Year | Recalls |
|---|---|
| 2023 | 4 |
Frequently asked questions
What is FDA product code PNR?
PNR is the FDA product code for enteral syringes with enteral specific connectors. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is PNR?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNR?
Across 34 cleared submissions the average was 166 days from receipt to decision (median 156).
Which companies have the most PNR clearances?
Neomed, Inc. (4); Covidien (4); CMT Health PTE., Ltd. (2); Pentaferte Italia S.R.L. (2); Jiangsu Caina Medical Co.,Ltd (2).
Have PNR devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2023-12-28.
Next steps
- Run an FDA pathway report with predicate devices for product code PNR
- Run a recall and safety report across every PNR manufacturer
- Watch product code PNR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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