Lada Intl., Inc.: FDA clearances and approvals
Lada Intl., Inc. has 7 FDA 510(k) clearances (first 1981, latest 1988), across 7 product codes in 4 review panels. Median 510(k) review time: 22 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| FPO | Stretcher, Wheeled | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| KNC | Table, Obstetric (And Accessories) | 1 | 1 |
| KZF | Device, Medical Examination, Ac Powered | 1 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
| NAD | Dressing, Wound, Occlusive | 1 | 1 |
Review panels
Most recent Lada Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872833 | BREATHGUARD APNEA MONITOR | BZQ | 1988-04-01 | 259 |
| K861410 | LIC MOBILE TRANSPORT STRETCHERS | FPO | 1986-04-22 | 7 |
| K830050 | MOLNLYCKE MEPORE STERILE SELF-ADHESIVE | NAD | 1983-06-02 | 143 |
| K830166 | MOLNLYCKE ETE STERILE NON-ADHERENT DRESS | NAB | 1983-02-09 | 22 |
| K830051 | MOLNLYCKE MESALT STERILE DRESSING | FRO | 1983-01-26 | 16 |
| K812141 | LIC OBSTETRICAL TABLE | KNC | 1981-08-25 | 28 |
| K812142 | LIC 180 MEDICAL LAMPS | KZF | 1981-08-13 | 16 |
Recalls
openFDA lists no recalls under a recalling firm named Lada Intl., Inc..
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 Lada Intl., Inc. have?
Lada Intl., Inc. has 7 FDA 510(k) clearances (first 1981, latest 1988), across 7 product codes in 4 review panels.
How long does FDA take to clear Lada Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lada Intl., Inc.'s cleared 510(k)s is 22 days.
What devices does Lada Intl., Inc. make?
Its most frequent FDA product codes are BZQ (Monitor, Breathing Frequency, 1); FPO (Stretcher, Wheeled, 1); FRO (Dressing, Wound, Drug, 1).
Has Lada Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lada Intl., Inc. Related entities may recall under other names.
Next steps
- See all 7 Lada Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZQ, Lada Intl., Inc.'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.