FDA product code MSH: Respirator, Surgical
MSH is the FDA product code for respirator, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 35 510(k) submissions under MSH, 1 in the last five years, from 24 different applicants. The average 510(k) review took 97 days (median 74); 112 days on average over the last three years. FDA has posted 3 recalls for MSH devices, 1 initiated in the last five years.
Definition
A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures subject to 21 CFR 878.9 and the conditions for exemption identified in 21 CFR 878.4040(b)(1).
Classification
| Field | Value |
|---|---|
| Device name | Respirator, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MSH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 118 |
| 2018 | 1 | 190 |
| 2024 | 1 | 112 |
Compare with all 510(k) review times · Search every MSH clearance
Top MSH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inovel, LLC | 5 | 2007-01-12 |
| Aearo Company | 3 | 2007-11-08 |
| Louis M. Gerson Co., Inc. | 3 | 2006-11-17 |
| 3M Company | 2 | 2013-02-11 |
| Moldex/Metric, Inc. | 2 | 2010-09-13 |
19 more applicants have MSH clearances. See the full list in Caduvo.
Most recent MSH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233022 | Owens & Minor (O&M) Halyard, Inc. | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | 2024-01-12 | 112 |
| K172963 | Master & Frank Enterprise Co., Ltd. | Master-Frank N95 Particulate Respirator | 2018-04-04 | 190 |
| K171116 | 3M Healthcare | 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S | 2017-08-10 | 118 |
| K160271 | San-M Package Co., Ltd. | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | 2016-07-15 | 164 |
| K141876 | Pasture Pharma Pte, Ltd. | Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator | 2015-10-28 | 474 |
Recalls for MSH devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-08-09.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code MSH?
MSH is the FDA product code for respirator, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is MSH?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MSH?
Across 35 cleared submissions the average was 97 days from receipt to decision (median 74).
Which companies have the most MSH clearances?
Inovel, LLC (5); Aearo Company (3); Louis M. Gerson Co., Inc. (3); 3M Company (2); Moldex/Metric, Inc. (2).
Have MSH devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2023-08-09.
Next steps
- Run an FDA pathway report with predicate devices for product code MSH
- Run a recall and safety report across every MSH manufacturer
- Watch product code MSH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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