FDA product code · Obstetrics/Gynecology · Class 2
HIH: Hysteroscope (And Accessories)
HIH is FDA's product code for "Hysteroscope (And Accessories)": a Class 2 device classified under 21 CFR 884.1690, reviewed by the Obstetrics/Gynecology panel.
510(k) review time for HIH
Across 55 510(k) clearances under HIH decided from 2018-01-01 to 2026-10-06, the median was 136 days from FDA receipt to decision. Half took between 87 and 238 days, and 80% were decided within 245 days. These are past clearances, not a forecast for a new submission.
| Fastest | 20 |
|---|---|
| 25th percentile | 87 |
| Median | 136 |
| 75th percentile | 238 |
| 80th percentile | 245 |
| 90th percentile | 268 |
| Slowest | 454 |
| Year | Median days | n |
|---|---|---|
| 2018 | 135 | 8 |
| 2019 | 91 | 14 |
| 2020 | 88 | 7 |
| 2024 | 148 | 6 |
| 2026 (to 10-06, partial) | 168 | 7 |
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.
HIH in the public FDA record
| 510(k) clearances, all years | 172 |
|---|---|
| Device recalls | 14 |
| Establishment listings | 421 |
| GUDID device identifiers | 1,289 |
Counts of records, not of devices or events. Adverse event reports for HIH 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 HIH
12 FDA recognized consensus standards cite HIH, 1 of them recognized only in part, among them ISO 8600-1 Fourth Edition 2015-10-15; ISO 8600-3 Second edition 2019-08; CIE ISO 11664-1:2019. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 9-110 ISO 8600-1 Fourth Edition 2015-10-15 — Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
- 9-123 ISO 8600-3 Second edition 2019-08 (partial recognition) — Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics.
- 9-124 CIE ISO 11664-1:2019 — Colorimetry - Part 1: CIE standard colorimetric observers
- 9-126 ISO CIE 11664-3 First edition 2019-06 — Colorimetry - Part 3: CIE tristimulus values
- 9-127 ISO CIE 11664-4 First edition 2019-06 — Colorimetry - Part 4: CIE 1976 L*a*b* colour space
- 9-129 ISO CIE 61966-2-1 First edition 1999-10 — Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)]
- 9-130 ISO 8600-6 Second edition 2020-09 — Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary
- 9-131 ISO 8600-5 Second Edition 2020-10 — Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics
- 9-139 CIE ISO 11664-5:2016 — Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u'v' uniform chromaticity scale diagram
- 9-146 ISO 8600-4 Third Edition 2023-01 — Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
- 9-147 ISO CIE 11664-2 First edition 2022-08 — Colorimetry - Part 2: CIE standard illuminants
- 9-148 ISO CIE 11664-6 Second edition 2022-08 — Colorimetry - Part 6: CIEDE2000 colour-difference formula
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.