Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BZO — Predicate Candidate Screening
88 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
90 days90th percentile
88clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953784 | UNICOR, INC. CORRUGATED TUBING | Unicor, Inc. | 1995-09-19 | 36 | 0 |
| K953785 | UNICOR, INC. VENTILATOR HOSES | Unicor, Inc. | 1995-09-18 | 35 | 0 |
| K952010 | PRIMA VENTILATOR HOSES | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952022 | PRIMA VOLUMN VENTILATORSS | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952012 | PRIMA CUSTOM ANESTESIA CIRCUIT | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K952011 | PRIMA BREATHING BAGS | Prima, Inc. | 1995-05-22 | 24 | 0 |
| K945740 | INFANT FLOW SYSTEM | Hamilton Medical, Inc. | 1995-03-23 | 120 | 3 |
| K944531 | PRIMA, INC. CORRUGATED TUBING | Prima, Inc. | 1994-12-02 | 78 | 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 |
| K935582 | TUBE, INHALER OXYGEN | Puritas Health Care, Inc. | 1994-01-14 | 57 | 0 |
| K934753 | STAR BREATHING CIRCUITS | Infrasonics Corp. | 1993-10-27 | 23 | 0 |
| K932706 | PRECISION MED PRODUCTS LTD. VENTILATOR HOSE | Precision Med Products, Ltd. | 1993-07-23 | 49 | 0 |
| K932712 | PRECISION MED PRODUCTS LTD VOLUME VENTILATORS | Precision Med Products, Ltd. | 1993-07-22 | 48 | 0 |
| K932560 | VOLUME VENTILATORS | Life Shield Healthcare Products, Inc. | 1993-07-22 | 56 | 0 |
| K932563 | VENTILATOR HOSES | Life Shield Healthcare Products, Inc. | 1993-07-16 | 50 | 0 |
| K932119 | CLEVELAND TUBING, INC. VENTILATOR HOSES | Cleveland Tubing, Inc. | 1993-06-23 | 51 | 0 |
| K922479 | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED | Intertech Resources, Inc. | 1992-10-30 | 157 | 0 |
| K921510 | GAS SAMPLING KIT MODIFICATION | Respiratory Support Products, Inc. | 1992-06-11 | 90 | 0 |
| K911328 | UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION | Intertech Resources, Inc. | 1991-08-15 | 142 | 0 |
| K903083 | NEONATAL VENTILATOR CIRCUIT | Hudson Respiratory Care, Inc. | 1990-12-27 | 168 | 0 |
| K903055 | EXTENDED LIFE CIRCUITS | Pharma Systems, Inc. | 1990-11-09 | 121 | 0 |
| K903404 | FLOCARE F | Flocare Medical | 1990-09-25 | 56 | 0 |
| K896439 | TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE | Ventlab Corp. | 1990-01-09 | 61 | 0 |
| K895853 | SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT | Sechrist Industries, Inc. | 1989-12-22 | 80 | 0 |
| K893760 | CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 | Nova-Ventrx | 1989-08-10 | 83 | 0 |
| K890822 | CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE) | Ventlab Corp. | 1989-05-05 | 77 | 0 |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | Life Design Systems, Inc. | 1989-03-20 | 76 | 0 |
| K884525 | PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT | Intertech/Ohio | 1988-12-16 | 50 | 0 |
| K882341 | QUICK CONNECT T ADAPTOR | Thayer Medical Corp. | 1988-07-18 | 41 | 0 |
| K880959 | LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY | Lifeguard Medical Products, Inc. | 1988-04-14 | 38 | 0 |
| K880637 | BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES | Baxter Healthcare Corp | 1988-04-11 | 55 | 0 |
| K874559 | BABYFLEX PATIENT CIRCUIT | Airoflex Medical, Inc. | 1987-12-21 | 47 | 0 |
| K873900 | PORTABLE VENTILATOR PATIENT CIRCUIT | Puritan Bennett Corp. | 1987-10-30 | 36 | 0 |
| K873927 | REUSEABLE BREATHING TUBES | Dryden Corp. | 1987-10-20 | 25 | 0 |
| K863756 | MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT | Nova-Ventrx | 1986-11-13 | 49 | 0 |
| K863910 | RAINCOAT | Artec Environmental Monitoring Division | 1986-10-20 | 12 | 0 |
| K863033 | PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS | Intertech/Ohio | 1986-08-20 | 9 | 0 |
| K860659 | END TIDAL CO2 SAMPLING CIRCUIT | Life Design Systems, Inc. | 1986-04-17 | 52 | 0 |
| K861286 | GAS SAMPLING KIT | Respiratory Support Products, Inc. | 1986-04-11 | 4 | 0 |
| K860879 | DISPOSABLE VENTILATOR CIRCUITS | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 | 23 | 0 |
| K860880 | VENTILATOR CIRCUITS (VARIOUS TYPES) | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 | 23 | 0 |
| K850151 | L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT | Life Products, Inc. | 1985-07-19 | 185 | 0 |
| K850600 | CO-AX VENTILATOR CIRCUIT | Nova-Ventrx | 1985-05-02 | 76 | 0 |
| K850703 | SAF T FLO VENTILATOR TUBING | Bivona Medical Technologies | 1985-03-25 | 32 | 0 |
| K844290 | L100D PATIENT CIRCUIT DUAL LINE | Life Products, Inc. | 1985-01-10 | 66 | 0 |
| K843036 | PATIENT BREATHING CIRCUIT | Infrasonics Corp. | 1984-08-15 | 13 | 0 |
| K842778 | AVATRON UNIVERSAL ADULT VOL. VENTILATOR | Avatron, Inc. | 1984-07-26 | 10 | 0 |
| K842389 | AVATRON DISPOSABLE I.P.P.B. CIRUCIT | Avatron, Inc. | 1984-06-26 | 8 | 0 |
| K841657 | PATIENT TUBING HYTREL SIEMENS-ELEMA | Siemens Elema AB | 1984-05-23 | 30 | 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