Avid N.I.T., Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Avid N.I.T., Inc.” (first 1995, latest 2002), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 166 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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 3 | 3 |
| IWJ | System, Applicator, Radionuclide, Manual | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| MIA | Needle, Spinal, Short Term | 1 | 1 |
Review panels
Most recent Avid N.I.T., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K014246 | AVID-NIT NERVE STIMULATION NEEDLES | CAZ | 2002-07-16 | 202 |
| K013231 | AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L | BSP | 2001-12-03 | 67 |
| K983218 | N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE | FCG | 1998-11-06 | 53 |
| K972595 | ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER | BSP | 1998-05-20 | 313 |
| K972554 | REGANES RADIONUCLIDE SEED MAGAZINE | IWJ | 1998-02-17 | 224 |
| K973037 | N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 | IWJ | 1998-01-27 | 166 |
| K973638 | N.I.T., INC. NEEDLE GUIDING TEMPLATE | IWJ | 1997-12-23 | 90 |
| K971645 | REGANES SPINAL NEEDLE (VARIOUS) | MIA | 1997-08-01 | 88 |
| K945965 | ATRAUMATIC PENCIL POINT SPINAL NEEDLE | BSP | 1995-08-02 | 238 |
Recalls
openFDA lists no recalls under a recalling firm named Avid N.I.T., 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.
- Avid Care Corp. (2 510(k)s)
- Avid Medical, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Avid N.I.T., Inc.?
FDA lists 9 510(k) clearances under the applicant name “Avid N.I.T., Inc.” (first 1995, latest 2002), across 5 product codes in 3 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 Avid N.I.T., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avid N.I.T., Inc. is 166 days.
Which FDA product codes appear under Avid N.I.T., Inc.?
The most frequent FDA product codes under this applicant name are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 3); IWJ (System, Applicator, Radionuclide, Manual, 3); CAZ (Anesthesia Conduction Kit, 1).
Next steps
- See all 9 Avid N.I.T., Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSP, Avid N.I.T., 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.