Helio Medical Supplies, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Helio Medical Supplies, Inc.” (first 1996, latest 2008), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 110 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 |
|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | 10 | 10 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
Review panels
- General Hospital (10)
- Neurology (1)
- Physical Medicine (1)
Most recent Helio Medical Supplies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080221 | EA STIMULATOR | GZJ | 2008-09-09 | 224 |
| K072778 | BRIO ACUPUNCTURE NEEDLES | MQX | 2007-11-19 | 52 |
| K062448 | LYRA ACUPUNCTURE NEEDLES | MQX | 2006-09-20 | 29 |
| K052723 | SEVEN STAR NEEDLE | MQX | 2006-01-13 | 106 |
| K050295 | PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES | MQX | 2005-03-25 | 46 |
| K043277 | C&G ACUPUNCTURE NEEDLE | MQX | 2005-02-08 | 74 |
| K024207 | VINCO BRAND ACUPUNCTURE NEEDLE | MQX | 2003-04-14 | 115 |
| K012583 | ACUGLIDE BRAND ACUPUNCTURE NEEDLES | MQX | 2001-12-11 | 123 |
| K991508 | ACUMASTER BRAND ACUPUNCTURE NEEDLE | MQX | 1999-08-27 | 120 |
| K991507 | KANGNIAN BRAND ACUPUNCTURE NEEDLE | MQX | 1999-08-27 | 120 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Helio Medical Supplies, 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 Helio Medical Supplies, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Helio Medical Supplies, Inc.” (first 1996, latest 2008), across 3 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 Helio Medical Supplies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Helio Medical Supplies, Inc. is 110 days.
Which FDA product codes appear under Helio Medical Supplies, Inc.?
The most frequent FDA product codes under this applicant name are MQX (Needle, Acupuncture, Single Use, 10); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); ILY (Lamp, Infrared, Therapeutic Heating, 1).
Next steps
- See all 12 Helio Medical Supplies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQX, Helio 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.