FDA product code · Obstetrics/Gynecology · Class 2
HIS: Condom
HIS is FDA's product code for "Condom": a Class 2 device classified under 21 CFR 884.5300, reviewed by the Obstetrics/Gynecology panel.
510(k) review time for HIS
Across 31 510(k) clearances under HIS decided from 2018-01-01 to 2026-10-06, the median was 143 days from FDA receipt to decision. Half took between 90 and 251 days, and 80% were decided within 258 days. These are past clearances, not a forecast for a new submission.
| Fastest | 45 |
|---|---|
| 25th percentile | 90 |
| Median | 143 |
| 75th percentile | 251 |
| 80th percentile | 258 |
| 90th percentile | 278 |
| Slowest | 387 |
| Year | Median days | n |
|---|---|---|
| 2021 | 233 | 5 |
| 2022 | 112 | 10 |
| 2025 | 99 | 5 |
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.
HIS in the public FDA record
| 510(k) clearances, all years | 401 |
|---|---|
| Establishment listings | 318 |
| GUDID device identifiers | 1,795 |
Counts of records, not of devices or events. Adverse event reports for HIS 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 HIS
10 FDA recognized consensus standards cite HIS, among them ANSI ASQ Z1.4-2003 (R2018); ASTM D6355-07(2022); ASTM D6499-18. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 5-62 ANSI ASQ Z1.4-2003 (R2018) — Sampling Procedures and Tables for Inspection by Attributes
- 6-214 ASTM D6355-07(2022) — Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
- 6-411 ASTM D6499-18 — Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
- 6-515 ASTM D6499-24 — Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
- 9-111 ISO 4074 Third edition 2015-10-15 — Natural latex rubber condoms - Requirements and test methods
- 9-115 ISO 29943-1 First edition 2017-07. — Condoms -- Guidance on clinical studies -- Part 1: Male condoms clinical function studies based on self-reports
- 9-117 ISO 16038 Second edition 2017-11 — Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms
- 9-120 ASTM D3492-16 — Standard Specification for Rubber Contraceptives (Male Condoms)
- 9-145 ASTM D7661-18 — Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms
- 9-86 ISO 16037 First edition 2002-05-15 (Amendment 1 2011-02-15) — Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)]
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.