510(k) · Cleared
ClearedPasture, Models: F550, A520
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pasture Pharma Pte, Ltd. · NZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
Cleared on Jan 23, 2009 after an 87-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Jan 23, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- NZJ
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 NZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K062070 | 3M 8612F Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…./io&317 Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies K062070 Labels/ Labeling: This device will be marketed NIOSH-certified N95 respirator for use by the general public in public health… |
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.
How does its category compare?
All NZJ devicesNZJ Respirator, N95, For Use By The General Public In Public Health Medical Emergencies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NZJ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NZJ
Too few NZJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NZJ
No recall names NZJ since 2007.
Adverse event reports per year · NZJ
1in 2021
MAUDE reports naming product code NZJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is a disposable filtering facepiece respirators intended for use by the general public in public health medical emergencies - PastureTM A520G Respirator and PastureTM F550G Respirator
Not designed for children.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083176: Pasture, Models: F550, A520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083176
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026