Myco Medical Supplies, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Myco Medical Supplies, Inc.” (first 1995, latest 2021), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 298 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 | 1 | 213 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 287 |
| 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 Myco Medical Supplies, Inc. took a median 250 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 3 | 3 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 2 |
| FMF | Syringe, Piston | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| GAL | Suture, Absorbable, Natural | 1 | 1 |
Review panels
Most recent Myco Medical Supplies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203668 | RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles | BSP | 2021-09-29 | 287 |
| K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | FMI | 2018-05-14 | 213 |
| K090426 | VAKU-8 BLOOD COLLECTION NEEDLES | FMI | 2009-06-12 | 113 |
| K042504 | CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER | FOZ | 2006-01-19 | 491 |
| K000592 | UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET | FPA | 2001-04-12 | 415 |
| K990519 | PHOENIX EPIDURAL & SPINAL NEEDLES | BSP | 2000-06-02 | 470 |
| K982646 | AILEE SUTURES AND AILEE NEEDLES | GAL | 1999-06-02 | 308 |
| K990388 | TUTOPLUS IV ADMINISTRATION SET | FPA | 1999-03-29 | 49 |
| K982098 | TUTODROP 1 AND TUTODROP 2 | FPA | 1999-03-01 | 259 |
| K963364 | GLASS VAN GLASS SYRINGES | FMF | 1998-05-01 | 613 |
2 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-11-06.
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.
- Myco Medical (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Myco Medical Supplies, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Myco Medical Supplies, Inc.” (first 1995, latest 2021), across 6 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 Myco Medical Supplies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Myco Medical Supplies, Inc. is 298 days.
Which FDA product codes appear under Myco Medical Supplies, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 3); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 2); FMF (Syringe, Piston, 2).
Next steps
- See all 12 Myco Medical Supplies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Myco Medical Supplies, 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.