Medical Research Laboratories, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Medical Research Laboratories, Inc.” (first 1981, latest 2002), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 105 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 7 | 7 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 5 | 5 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (15)
- Anesthesiology (2)
- Neurology (1)
Most recent Medical Research Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021168 | JUMP START, MODEL 970300 | MKJ | 2002-06-26 | 76 |
| K012766 | PORTABLE INTENSIVE CARE UNIT | MKJ | 2002-01-23 | 159 |
| K012030 | PORTABLE INTENSIVE CARE UNIT | MKJ | 2001-09-24 | 88 |
| K010207 | PORTABLE INSTENSIVE CARE UNIT | MKJ | 2001-06-14 | 142 |
| K002232 | AEDEFIBRILLATOR | MKJ | 2000-12-06 | 135 |
| K000712 | PORTABLE INTENSIVE CARE UNIT, MODEL PIC | CCK | 2000-04-27 | 56 |
| K983307 | MODIFICATION TO PORTABLE INTENSIVE CARE UNIT | MKJ | 1998-11-20 | 60 |
| K974034 | PORTABLE INTENSIVE CARE UNIT | DRO | 1998-03-02 | 130 |
| K952085 | DPD DEFIBRILLATOR | LDD | 1995-06-05 | 33 |
| K935922 | 360 SLX ADVISORY DEFIBRILLATOR | MKJ | 1994-12-22 | 374 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Research Laboratories, 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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Research Laboratories, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Medical Research Laboratories, Inc.” (first 1981, latest 2002), across 8 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 Medical Research Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Research Laboratories, Inc. is 105 days.
Which FDA product codes appear under Medical Research Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 7); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 5); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 2).
Next steps
- See all 19 Medical Research Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Medical Research Laboratories, 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.