FDA product code · Gastroenterology, Urology · Class 2
PNR: Enteral Syringes With Enteral Specific Connectors
PNR is FDA's product code for "Enteral Syringes With Enteral Specific Connectors": a Class 2 device classified under 21 CFR 876.5980, reviewed by the Gastroenterology, Urology panel.
510(k) review time for PNR
Across 20 510(k) clearances under PNR decided from 2018-01-01 to 2026-10-06, the median was 157 days from FDA receipt to decision. Half took between 78 and 258 days, and 80% were decided within 262 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 78 |
| Median | 157 |
| 75th percentile | 258 |
| 80th percentile | 262 |
| 90th percentile | 287 |
| Slowest | 337 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
PNR in the public FDA record
| 510(k) clearances, all years | 34 |
|---|---|
| GUDID device identifiers | 450 |
Counts of records, not of devices or events. Adverse event reports for PNR are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite PNR
2 FDA recognized consensus standards cite PNR, among them ISO 80369-3 First Edition 2016-07-01; ISO 18250-3 First edition 2018-06. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 5-123 ISO 80369-3 First Edition 2016-07-01 — Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
- 5-139 ISO 18250-3 First edition 2018-06 — Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.
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