Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Research Laboratories, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
284 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021168 | JUMP START, MODEL 970300 | Medical Research Laboratories, Inc. | 2002-06-26 | 76 | 7 |
| K012766 | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 2002-01-23 | 159 | 0 |
| K012030 | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 2001-09-24 | 88 | 0 |
| K010207 | PORTABLE INSTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 2001-06-14 | 142 | 0 |
| K002232 | AEDEFIBRILLATOR | Medical Research Laboratories, Inc. | 2000-12-06 | 135 | 3 |
| K000712 | PORTABLE INTENSIVE CARE UNIT, MODEL PIC | Medical Research Laboratories, Inc. | 2000-04-27 | 56 | 0 |
| K983307 | MODIFICATION TO PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 1998-11-20 | 60 | 0 |
| K974034 | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | 1998-03-02 | 130 | 3 |
| K952085 | DPD DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1995-06-05 | 33 | 0 |
| K935922 | 360 SLX ADVISORY DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1994-12-22 | 374 | 0 |
| K930548 | DPD DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1993-06-25 | 142 | 0 |
| K884869 | MODIFIED MRL NEUROPROBE SYSTEM V | Medical Research Laboratories, Inc. | 1989-06-06 | 197 | 0 |
| K885191 | MRL BLOOD PRESSURE MONITOR | Medical Research Laboratories, Inc. | 1989-05-23 | 158 | 0 |
| K880932 | MRL PACETTE, 450SLL | Medical Research Laboratories, Inc. | 1988-12-16 | 284 | 0 |
| K882664 | MRL OXIMETER | Medical Research Laboratories, Inc. | 1988-09-16 | 81 | 0 |
| K874204 | 450SLL DEFIBRILLATOR | Medical Research Laboratories, Inc. | 1988-01-28 | 105 | 0 |
| K840900 | PORTA PAK 90 | Medical Research Laboratories, Inc. | 1984-06-11 | 104 | 0 |
| K833751 | PORTA PULSE III #D320 | Medical Research Laboratories, Inc. | 1984-01-11 | 77 | 0 |
| K803247 | TRANSCUTANEOUS ELECT. NERVE STIMULATOR | Medical Research Laboratories, Inc. | 1981-03-20 | 87 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda