Xanar, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Xanar, Inc.” (first 1983, latest 1986), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 151 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 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 1 | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| LNK | Laser For Gastro-Urology Use | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (6)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent Xanar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861688 | XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 | GEX | 1986-10-03 | 154 |
| K852436 | AMBULASE | GEX | 1986-04-18 | 312 |
| K860496 | MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY | LNK | 1986-03-14 | 32 |
| K853620 | MODEL XA-50 - CO2 SURGICAL LASER | GEX | 1986-01-24 | 148 |
| K850818 | CO 2 SURGICAL LASER SYSTEM NA-120 | GEX | 1985-08-15 | 168 |
| K850805 | CO 2 SURGICAL LASER SYSTEM MODEL NA-40 | GEX | 1985-08-15 | 169 |
| K850804 | CO 2 SURGICAL LASER SYSTEM NA-30 | GEX | 1985-08-15 | 169 |
| K844087 | XANAR MODEL XSE-300 SMOKE EVACULATER | FYD | 1985-02-27 | 128 |
| K841860 | CO2 SURGICAL LASER SYSTEM XML-10 | EWG | 1984-11-08 | 188 |
| K833325 | AMBULASE XAM-15 XANAR SURG. LASER | — | 1984-01-26 | 121 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Xanar, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Xanar, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Xanar, Inc.” (first 1983, latest 1986), across 5 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xanar, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xanar, Inc. is 151 days.
Which FDA product codes appear under Xanar, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6); EWG (Laser, Ent Microsurgical Carbon-Dioxide, 1); FYD (Apparatus, Exhaust, Surgical, 1).
Next steps
- See all 12 Xanar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Xanar, 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.