Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CAI — Predicate Candidate Screening
184 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
176 days90th percentile
184clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954480 | CONDENSATE COLLECTION KIT | Nova-Ventrx | 1995-12-29 | 94 | 0 |
| K953788 | UNICOR, INC. GAS SAMPLING LINES & CONNECTORS | Unicor, Inc. | 1995-09-19 | 36 | 0 |
| K953787 | UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT | Unicor, Inc. | 1995-09-19 | 36 | 0 |
| K952014 | PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952019 | PRIMA ADULT GAS SAMPLING CIRCUITS | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952018 | PRIMA COAXIAL CIRCUITS | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952016 | PRIMA PEDIATRIC GAS SAMPLING CIRCUITS | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952017 | PRIMA MAPLESON D CIRCUIT | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952020 | PRIMA PEDIATRIC ANESTHESIA CIRCUITS | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952009 | PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Prima, Inc. | 1995-05-19 | 21 | 0 |
| K945565 | SPIRO-FLEX | Inhalation Plastics | 1995-01-13 | 119 | 0 |
| K932288 | NEONATAL BREATHING CIRCUIT MODIFICATION | Simplex Medical Systems, Inc. | 1994-12-30 | 599 | 0 |
| K945984 | MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REE | Meridian Medical Systems, Inc. | 1994-12-27 | 19 | 0 |
| K944533 | PRIMA, INC. ADULT ANESTHESIA CIRCUIT | Prima, Inc. | 1994-11-29 | 75 | 0 |
| K944429 | PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING | Precision Thermoplastic Components, Inc. | 1994-11-18 | 67 | 0 |
| K945314 | CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING | Cleveland Tubing, Inc. | 1994-11-18 | 17 | 0 |
| K940890 | CORRUGATED TUBING | Cleveland Tubing, Inc. | 1994-11-10 | 289 | 0 |
| K940889 | CONNECTORS AND AIRWAY EXTENSIONS | Cleveland Tubing, Inc. | 1994-11-10 | 258 | 0 |
| K944295 | KARL STORZ LARYNGOSCOPE ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1994-10-04 | 36 | 0 |
| K942128 | M.A.G. INC. ADULT GAS SAMPLING CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942123 | M.A.G. INC. VENTILATOR HOSES | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942135 | M.A.G. INC. COAXIAL CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942136 | M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942126 | M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942132 | M.A.G. INC. HYPERINFLATION SYSTEM | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942129 | M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942122 | PEDIATRIC ANESTHESIA CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942133 | M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942131 | M.A.G. INC. GUEDEL AIRWAYS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942127 | M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942130 | M.A.G. INC. MAPLESON D CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942125 | VOLUME VENTILATOR | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942124 | GAS SAMPLING LINES AND CONNECTORS CIRCUITS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942134 | M.A.G. INC. BREALTHING BAGS | Mag, Inc. | 1994-06-22 | 50 | 0 |
| K942568 | ADULT ANESTHESIA BREATHING CIRCUIT | Med-Plastics Intl., Inc. | 1994-06-10 | 10 | 0 |
| K942570 | MAPLESON D CIRCUIT | Med-Plastics Intl., Inc. | 1994-06-10 | 10 | 0 |
| K934462 | ADULT ANESTHESIA BREATHING CIRCUIT KITS | Zefon Medical Products | 1994-03-01 | 169 | 0 |
| K935168 | ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS | Bill Olson Corp. | 1994-02-07 | 103 | 0 |
| K932780 | MALE/MALE LUER TRANSFER TUBING | Innovations For Mechanical Ventilation, Inc. | 1994-01-24 | 229 | 0 |
| K932781 | DUAL VALVED RESPIRATORY T | Innovations For Mechanical Ventilation, Inc. | 1994-01-24 | 229 | 0 |
| K931487 | BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE | Bird Life Design | 1993-12-16 | 267 | 0 |
| K935044 | EASYFLOW AIRWAY ADAPTER | Easyflow Airway Systems, Inc. | 1993-11-18 | 29 | 0 |
| K933641 | BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIB | Bird Life Design | 1993-10-15 | 80 | 0 |
| K930713 | THE INFANT FLOW SYSTEM | Sechrist Industries, Inc. | 1993-09-16 | 217 | 0 |
| K932562 | GAS SAMPLING LINES AND CONNECTORS | Life Shield Healthcare Products, Inc. | 1993-07-23 | 57 | 0 |
| K932708 | PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS | Precision Med Products, Ltd. | 1993-07-23 | 49 | 0 |
| K932710 | GAS SAMPLING LINES AND CONNECTORS | Precision Med Products, Ltd. | 1993-07-23 | 49 | 0 |
| K932707 | ADULT ANESTHESIA BREATHING CIRCUIT | Precision Med Products, Ltd. | 1993-07-23 | 49 | 0 |
| K932497 | PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING | Precision Med Products, Ltd. | 1993-07-22 | 59 | 0 |
| K932590 | ADULT GAS SAMPLING CIRCUITS | Merit Medical Systems, Inc. | 1993-07-22 | 56 | 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