Moss Tubes, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Moss Tubes, Inc.” (first 1999, latest 2019), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 113 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Moss Tubes, Inc. took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| BSS | Tube, Nasogastric | 1 | 1 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 1 | 1 |
Review panels
Most recent Moss Tubes, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190414 | Moss Gastrostomy Tube, Moss Nasal Tube Mark IV | PIF | 2019-06-14 | 113 |
| K990389 | MOSS GASTROSTOMY TUBE | KNT | 1999-03-22 | 42 |
| K984628 | MODIFICATION OF MOSS P.E.G. TRAY | KNT | 1999-03-17 | 77 |
| K984629 | MOSS TUBES, INC. NASAL TUBE - MARK IV | BSS | 1999-03-02 | 62 |
| K984310 | MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE | KNT | 1999-02-24 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Moss Tubes, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Moss Medical Products (8 510(k)s)
- Moss Point Glove Co. (1 510(k)s)
- Moss Rehabilation Hospital (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Moss Tubes, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Moss Tubes, Inc.” (first 1999, latest 2019), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Moss Tubes, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Moss Tubes, Inc. is 77 days.
Which FDA product codes appear under Moss Tubes, Inc.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 3); BSS (Tube, Nasogastric, 1); PIF (Gastrointestinal Tubes With Enteral Specific Connectors, 1).
Next steps
- See all 5 Moss Tubes, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Moss Tubes, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.