FDA product code · General, Plastic Surgery · Class 2
OMP: Negative Pressure Wound Therapy Powered Suction Pump
OMP is FDA's product code for "Negative Pressure Wound Therapy Powered Suction Pump": a Class 2 device classified under 21 CFR 878.4780, reviewed by the General, Plastic Surgery panel.
510(k) review time for OMP
Across 82 510(k) clearances under OMP decided from 2018-01-01 to 2026-10-06, the median was 244 days from FDA receipt to decision. Half took between 127 and 292 days, and 80% were decided within 314 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 127 |
| Median | 244 |
| 75th percentile | 292 |
| 80th percentile | 314 |
| 90th percentile | 418 |
| Slowest | 502 |
| Year | Median days | n |
|---|---|---|
| 2018 | 214 | 13 |
| 2019 | 249 | 15 |
| 2020 | 179 | 6 |
| 2021 | 238 | 9 |
| 2022 | 229 | 10 |
| 2023 | 291 | 8 |
| 2024 | 181 | 9 |
| 2025 | 127 | 5 |
| 2026 (to 10-06, partial) | 141 | 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.
OMP in the public FDA record
| 510(k) clearances, all years | 214 |
|---|---|
| Device recalls | 47 |
| Establishment listings | 403 |
| GUDID device identifiers | 935 |
Counts of records, not of devices or events. Adverse event reports for OMP 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 OMP
5 FDA recognized consensus standards cite OMP, among them ISO 10079-2 Fourth edition 2022-03; ISO 10079-3 Fourth edition 2022-03; ISO 10079-1 Fourth edition 2022-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 1-155 ISO 10079-2 Fourth edition 2022-03 — Medical suction equipment - Part 2: Manually powered suction equipment
- 1-156 ISO 10079-3 Fourth edition 2022-03 — Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
- 1-157 ISO 10079-1 Fourth edition 2022-03 — Medical suction equipment - Part 1: Electrically powered suction equipment
- 1-158 ISO 10079-4 First edition 2021-08 — Medical suction equipment - Part 4: General requirements
- 1-203 ISO 10079-1 Fourth edition 2022-03 [Including AMD1:2026] — Medical suction equipment - Part 1: Electrically powered suction equipment [Including Amendment 1 (2026)]
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.