Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med-Plastics Intl., Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
56 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Med-Plastics Intl., Inc. | 1995-06-08 | 169 | 0 |
| K942568 | ADULT ANESTHESIA BREATHING CIRCUIT | Med-Plastics Intl., Inc. | 1994-06-10 | 10 | 0 |
| K942569 | VENTILATOR HOSE | Med-Plastics Intl., Inc. | 1994-06-10 | 10 | 0 |
| K942572 | VOLUME VENTILATOR | Med-Plastics Intl., Inc. | 1994-06-10 | 10 | 0 |
| K942570 | MAPLESON D CIRCUIT | Med-Plastics Intl., Inc. | 1994-06-10 | 10 | 0 |
| K942567 | MASS SPECTROMETRY MONITORING LINES AND CONNECTORS | Med-Plastics Intl., Inc. | 1994-06-10 | 10 | 0 |
| K942571 | HYPER-INFLATION BAG | Med-Plastics Intl., Inc. | 1994-06-10 | 10 | 0 |
| K932576 | PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Med-Plastics Intl., Inc. | 1993-07-22 | 56 | 0 |
| K932578 | ADULT GAS SAMPLING CIRCUITS | Med-Plastics Intl., Inc. | 1993-07-22 | 56 | 0 |
| K932575 | ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | Med-Plastics Intl., Inc. | 1993-07-22 | 56 | 0 |
| K932577 | PEDIATRIC GAS SAMPLING | Med-Plastics Intl., Inc. | 1993-07-22 | 56 | 0 |
| K932579 | COAXIAL CIRCUITS | Med-Plastics Intl., Inc. | 1993-07-16 | 50 | 0 |
| K932582 | CUSTOM ANESTHESIA CIRCUITS | Med-Plastics Intl., Inc. | 1993-07-16 | 50 | 0 |
| K932581 | BREATHING BAGS | Med-Plastics Intl., Inc. | 1993-07-16 | 50 | 0 |
| K932580 | PEDIATRIC ANESTHESIA CIRCUITS | Med-Plastics Intl., Inc. | 1993-07-16 | 50 | 0 |
| K931038 | CONNECTORS AND AIRWAY EXTENSIONS | Med-Plastics Intl., Inc. | 1993-04-08 | 38 | 0 |
| K930760 | MED-PLASTICS INTL., INC. BREATHING FILTER | Med-Plastics Intl., Inc. | 1993-03-11 | 27 | 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