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FDA product code · General Hospital · Class 2

LHI: Set, I.V. Fluid Transfer

LHI is FDA's product code for "Set, I.V. Fluid Transfer": a Class 2 device classified under 21 CFR 880.5440, reviewed by the General Hospital panel.

510(k) review time for LHI

Across 38 510(k) clearances under LHI decided from 2018-01-01 to 2026-10-06, the median was 225 days from FDA receipt to decision. Half took between 111 and 280 days, and 80% were decided within 294 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, LHI, decisions 2018-01-01 to 2026-10-06 (n = 38)
Fastest28
25th percentile111
Median225
75th percentile280
80th percentile294
90th percentile368
Slowest424
Median days by decision year, LHI (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20223005
2023905
20241669
20251966

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.

LHI in the public FDA record

Records naming LHI, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years206
Device recalls61
Establishment listings447
GUDID device identifiers946

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

10 FDA recognized consensus standards cite LHI, among them ISO 8536-7 Third edition 2009-01-15; ISO 8536-3 Third edition 2009-06-01; ISO 8536-2 Third edition 2010-03-15. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 6-216 ISO 8536-7 Third edition 2009-01-15 — Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles
  • 6-240 ISO 8536-3 Third edition 2009-06-01 — Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles
  • 6-242 ISO 8536-2 Third edition 2010-03-15 — Infusion equipment for medical use - Part 2: Closures for infusion bottles
  • 6-273 ISO 23908 First edition 2011-06-11 — Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles introducers for catheters and needles used for blood sampling
  • 6-276 ISO 8536-1 Fourth edition 2011-09-01 — Infusion equipment for medical use - Part 1: Infusion glass bottles
  • 6-410 ISO 8536-6 Third edition 2016-12-01 — Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
  • 6-447 ISO 8536-4 Sixth edition 2019-09 — Infusion equipment for medical use - Part 4: Infusion sets for single use gravity feed
  • 6-481 ANSI AAMI CN27:2021 — General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
  • 6-506 ISO 8536-2 Fourth edition 2023-01 — Infusion equipment for medical use - Part 2: Closures for infusion bottles
  • 6-507 ISO 23908 Second Edition 2024-12 — Sharps injury protection - Sharps protection mechanisms for single-use needles introducers for catheters and needles used for blood testing monitoring sampling and medical substance administration - Requirements and test methods

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

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