Habley Medical Technology Corp.: FDA clearances and approvals
Habley Medical Technology Corp. has 5 FDA 510(k) clearances (first 1987, latest 1996), across 3 product codes in 3 review panels. Median 510(k) review time: 70 days.
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 |
|---|---|---|---|
| FMF | Syringe, Piston | 3 | 3 |
| EJI | Syringe, Cartridge | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
Review panels
- General Hospital (3)
- Clinical Chemistry (1)
- Dental (1)
Most recent Habley Medical Technology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955164 | S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM) | FMF | 1996-03-20 | 128 |
| K903007 | MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER | EJI | 1990-09-19 | 70 |
| K881980 | RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE | FMF | 1988-06-28 | 47 |
| K880594 | VACUGUARD(TM) | JKA | 1988-04-28 | 77 |
| K871007 | ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE | FMF | 1987-04-30 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Habley Medical Technology Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Habley Medical Technology Corp. have?
Habley Medical Technology Corp. has 5 FDA 510(k) clearances (first 1987, latest 1996), across 3 product codes in 3 review panels.
How long does FDA take to clear Habley Medical Technology Corp.'s 510(k)s?
The median time from FDA receipt to decision across Habley Medical Technology Corp.'s cleared 510(k)s is 70 days.
What devices does Habley Medical Technology Corp. make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 3); EJI (Syringe, Cartridge, 1); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 1).
Has Habley Medical Technology Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Habley Medical Technology Corp. Related entities may recall under other names.
Next steps
- See all 5 Habley Medical Technology Corp. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Habley Medical Technology Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.