Axon Systems, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Axon Systems, Inc.” (first 1986, latest 2009), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 103 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 7 | 7 |
| GWQ | Full-Montage Standard Electroencephalograph | 4 | 4 |
| GXZ | Electrode, Needle | 2 | 2 |
| ETN | Stimulator, Nerve | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Neurology (14)
- Ear, Nose and Throat (1)
Most recent Axon Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090838 | STIMULUS/DISSECTION INSTRUMENTS | ETN | 2009-07-20 | 115 |
| K062996 | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES | GXZ | 2007-01-12 | 102 |
| K062198 | SUNSPOTS PRE-GELLED SURFACE ELECTRODES | GXY | 2006-12-19 | 140 |
| K061639 | ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON | GWF | 2006-11-01 | 142 |
| K061113 | ORTHOMON | GWF | 2006-05-23 | 32 |
| K050798 | ECLIPSE NEUROLOGICAL WORKSTATION | GWF | 2005-08-15 | 139 |
| K050194 | AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES | GXZ | 2005-04-26 | 89 |
| K032741 | EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION | GWF | 2003-12-16 | 103 |
| K022785 | EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION | GWQ | 2002-10-09 | 48 |
| K010697 | UNIQUE AMBULATORY EEG | GWQ | 2001-06-06 | 90 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Axon Systems, 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.
- Axon Instruments, Inc. (3 510(k)s)
- Axon Medical, Inc. (2 510(k)s)
- Axon Medical Technologies Corp. (1 510(k)s)
- Axon Spine Medical System (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Axon Systems, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Axon Systems, Inc.” (first 1986, latest 2009), across 5 product codes in 2 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 Axon Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Axon Systems, Inc. is 103 days.
Which FDA product codes appear under Axon Systems, Inc.?
The most frequent FDA product codes under this applicant name are GWF (Stimulator, Electrical, Evoked Response, 7); GWQ (Full-Montage Standard Electroencephalograph, 4); GXZ (Electrode, Needle, 2).
Next steps
- See all 15 Axon Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWF, Axon Systems, 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.