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FDA product code · Gastroenterology, Urology · Class 2

PIF: Gastrointestinal Tubes With Enteral Specific Connectors

PIF is FDA's product code for "Gastrointestinal Tubes 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 PIF

Across 32 510(k) clearances under PIF decided from 2018-01-01 to 2026-10-06, the median was 199 days from FDA receipt to decision. Half took between 106 and 247 days, and 80% were decided within 252 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, PIF, decisions 2018-01-01 to 2026-10-06 (n = 32)
Fastest43
25th percentile106
Median199
75th percentile247
80th percentile252
90th percentile274
Slowest337

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.

PIF in the public FDA record

Records naming PIF, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years51
Device recalls112
Establishment listings143
GUDID device identifiers1,031

Counts of records, not of devices or events. Adverse event reports for PIF 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 PIF

3 FDA recognized consensus standards cite PIF, among them ISO 80369-3 First Edition 2016-07-01; ISO 18250-3 First edition 2018-06; ISO 20695 First edition 2020-03. 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
  • 9-138 ISO 20695 First edition 2020-03 — Enteral feeding systems - Design and testing

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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