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
FDA 510(k) clearance K141876 · decided 2015-10-28
Clearance details
- K-number
- K141876
- Device name
- 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
- Applicant
- Pasture Pharma Pte, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-11
- Decision date
- 2015-10-28
- Days to decision
- 474 days
- Clearance type
- Traditional
- Product code
- MSH
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Murrieta, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| 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 (K233022) | Owens & Minor (O&M) Halyard, Inc. | 2024-01-12 |
| Master-Frank N95 Particulate Respirator (K172963) | Master & Frank Enterprise Co., Ltd. | 2018-04-04 |
| 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S (K171116) | 3M Healthcare | 2017-08-10 |
| N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 (K160271) | San-M Package Co., Ltd. | 2016-07-15 |
| 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK (K121069) | 3M Company | 2013-02-11 |
| BARRIER N95 PARTICULATE RESPIRATOR (K102923) | Molnlycke Health Care | 2010-11-19 |
| PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES (K102092) | Prestige Ameritech | 2010-10-06 |
| MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 (K102173) | Moldex/Metric, Inc. | 2010-09-13 |
| SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150 (K100139) | Safelife Corp. | 2010-05-04 |
| N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 (K092824) | Alpha Protech, Inc. | 2009-10-21 |
| DS N95 SURGICAL MASKS AND FLAT SURGICAL (K090131) | Shanghai Dasheng Health Products | 2009-04-27 |
| HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 (K080827) | Handan Hengyong Protective & Clean Products Co., L | 2008-04-04 |
Recalls involving this device
No recalls on record reference this clearance.