Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medipart Jerry Alexander · Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
168 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K896885 | DISPOSABLE RESPIRTORY KIT (MP-200) | Medipart Jerry Alexander | 1990-02-26 | 80 | 0 |
| K896125 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M | Medipart Jerry Alexander | 1990-02-01 | 101 | 0 |
| K896476 | DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD | Medipart Jerry Alexander | 1990-01-22 | 70 | 0 |
| K896475 | DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD | Medipart Jerry Alexander | 1990-01-22 | 70 | 0 |
| K896124 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 | Medipart Jerry Alexander | 1990-01-22 | 91 | 0 |
| K894138 | MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD | Medipart Jerry Alexander | 1989-09-26 | 105 | 0 |
| K893532 | RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 | Medipart Jerry Alexander | 1989-08-21 | 105 | 0 |
| K862784 | MP-XMO DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862792 | MP-066 RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862790 | MP-01X-I DISPOSABLE FILTER KIT | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862787 | MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862783 | MP-XMV DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862786 | MP-50T DISPOSABLE BREATHING CIRCUIT FILTER | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862785 | MP-1204 DISPOSABLE BACTERIA FILTER | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862788 | MP-4400 MOUTHPIECE-FLANGE SEAL | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862789 | MP-01X DISPOSABLE BACTERIA FILTER KIT | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862794 | MP-070 RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862791 | MP-30XM-IE FACE MASK AND FILTER KIT | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862781 | MP-XMM DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862795 | MP-070-M RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862782 | MP-XML DISPOSABLE FACE MASK | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K862793 | MP-066-M RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 | 9 | 0 |
| K854550 | MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA | Medipart Jerry Alexander | 1985-12-19 | 36 | 0 |
| K854551 | MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S | Medipart Jerry Alexander | 1985-12-19 | 36 | 0 |
| K853576 | MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M | Medipart Jerry Alexander | 1985-11-07 | 73 | 0 |
| K853569 | MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING | Medipart Jerry Alexander | 1985-11-07 | 73 | 0 |
| K853579 | MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133 | Medipart Jerry Alexander | 1985-11-07 | 73 | 0 |
| K853570 | MEDIPART DRIERITE MP-1002 | Medipart Jerry Alexander | 1985-11-07 | 73 | 0 |
| K853577 | MEDIPART BACTERIA FILTER MP-2615 | Medipart Jerry Alexander | 1985-10-30 | 65 | 0 |
| K853578 | MEDIPART DISPOS. NOSE CLIP MP-2001 | Medipart Jerry Alexander | 1985-10-29 | 64 | 0 |
| K853572 | MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 | Medipart Jerry Alexander | 1985-10-29 | 64 | 0 |
| K853574 | MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 | Medipart Jerry Alexander | 1985-10-29 | 64 | 0 |
| K853571 | MEDIPART SODA LIME MP-3522 | Medipart Jerry Alexander | 1985-10-29 | 64 | 0 |
| K853575 | MEDIPART MOUTHPIECE MP-1010 | Medipart Jerry Alexander | 1985-10-29 | 64 | 0 |
| K853573 | MEDIPART FACE MASK HEADSTRAP MP-9100 | Medipart Jerry Alexander | 1985-10-29 | 64 | 0 |
| K851198 | MEDIPART LUNG AEROSOL KIT MP-1012A | Medipart Jerry Alexander | 1985-09-10 | 168 | 0 |
| K851199 | MEDIPART LUNG AEROSOL KIT MP-1012A-M | Medipart Jerry Alexander | 1985-09-10 | 168 | 0 |
| K851200 | MEDIPART LUNG AEROSOL KIT MP-1024A | Medipart Jerry Alexander | 1985-09-10 | 168 | 0 |
| K851201 | MEDIPART LUND AEROSOL KIT MP-1024A-M | Medipart Jerry Alexander | 1985-09-10 | 168 | 0 |
| K850836 | MEDIPART FACE MASK MP-XM-I | Medipart Jerry Alexander | 1985-08-19 | 171 | 0 |
| K850837 | MEDIPART FACE MASK & FILTER MP-30XM-I | Medipart Jerry Alexander | 1985-08-19 | 171 | 0 |
| K850367 | MEDIPART XENON BREATHING KIT MP-02XM-I | Medipart Jerry Alexander | 1985-04-30 | 90 | 0 |
| K850366 | MEDIPART XENON BREATHING KIT MP-OIXM-I | Medipart Jerry Alexander | 1985-04-30 | 90 | 0 |
| K844496 | MEDIPART XENON BREATHING KIT MP-01XM | Medipart Jerry Alexander | 1984-12-24 | 34 | 0 |
| K844495 | MEDIPART XENON BREATHING KIT MP-02XM | Medipart Jerry Alexander | 1984-12-17 | 27 | 0 |
| K844493 | MEDIPART FACE MASK & FILTER MP-30XM | Medipart Jerry Alexander | 1984-12-04 | 14 | 0 |
| K844491 | MEDIPART FILTER & TUBING MP-02X | Medipart Jerry Alexander | 1984-12-04 | 14 | 0 |
| K844494 | MEDIPART FACE MASK MP-XM | Medipart Jerry Alexander | 1984-12-04 | 14 | 0 |
| K844492 | MEDIPART BACTERIA FILTER MP-30X | Medipart Jerry Alexander | 1984-12-04 | 14 | 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