510(k) · Cleared
ClearedPasture 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pasture Pharma Pte, Ltd. · MSH Respirator, Surgical
Cleared on Oct 28, 2015 as substantially equivalent to K070139 (Survivair, Inc., 2007) after a 474-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Oct 28, 2015
- Review
- 474 days
- Class
- Class II
- Product code
- MSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922507 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK922507 Gerson Isolair Apr Particulate Surgical MaskLouis M. Gerson Co., Inc. · 1992
- 4 generations backK960778 Isolair Apr Type N95Louis M. Gerson Co., Inc. · 1996
- 3 generations backK041855 Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004
- 2 generations backK051182 Inovel Health Care Model N95 Particulate Respirators and Surgical…Inovel, LLC · 2005 · Recalled
- 1 generation backK070139 Willson One-Fit Healthcare Particle Respirator and Surgical Mask…Survivair, Inc. · 2007
- This deviceK141876 Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95…Pasture Pharma Pte, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922507 | Gerson Isolair Apr Particulate Surgical Mask | Louis M. Gerson Co., Inc. | 1992 | — |
| −4 | K960778 | Isolair Apr Type N95 | Louis M. Gerson Co., Inc. | 1996 | — |
| −3 | K041855 | Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S | Aearo Co. | 2004 | — |
| −2 | K051182 | Inovel Health Care Model N95 Particulate Respirators and Surgical Masks | Inovel, LLC | 2005 | 1 |
| −1 | K070139 | Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 | Survivair, Inc. | 2007 | — |
| 0 (this device) | K141876 | Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator… | Pasture Pharma Pte, Ltd. | 2015 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSH device
- #1 K233022 Halyard Fluidshield 3 N95 Particulate Filter…score 6.7 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070139 | Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095Summary page 5…lassification Name: Surgical Apparel Regulation: 21 CFR §878.4040 Class: Class II Classification panel: General and Plastic Surgery Product Code: MSH Predicate Device: K070139 WILLSON ONE-FIT HEALTHCARE PARTICLE RESPIRATOR AND SURGICAL MASK, HC-NB095 SURVIVAIR, INC Intended Use: Pasture F550S, Pasture… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K070139.
How does its category compare?
All MSH devicesMSH Respirator, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MSH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MSH
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSH
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSH
10in 2025
MAUDE reports naming product code MSH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 78 | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 4 | 60 | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 71 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141876 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141876: 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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141876
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026