Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BTC — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
117 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181424 | PeDIA | Pedia, LLC | 2018-09-25 | 117 | 0 |
| K940220 | REBREATHER BAGS | Zefon Medical Products | 1994-05-27 | 126 | 0 |
| K932496 | PRECISION MED PRODUCTS, LTD. BREATHING BAGS | Precision Med Products, Ltd. | 1993-07-16 | 52 | 0 |
| K932581 | BREATHING BAGS | Med-Plastics Intl., Inc. | 1993-07-16 | 50 | 0 |
| K932584 | BREATHING BAGS | Merit Medical Systems, Inc. | 1993-07-16 | 50 | 0 |
| K932191 | BREATHING BAGS | Life Shield Healthcare Products, Inc. | 1993-07-02 | 57 | 0 |
| K894906 | ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER | Med-Tek Corp. | 1989-09-18 | 48 | 0 |
| K880680 | KING SYSTEMS, BREATHING BAG | King Systems Corp. | 1988-03-03 | 13 | 0 |
| K864822 | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS | Surgidyne, Inc. | 1987-01-15 | 37 | 0 |
| K841411 | ROLLED NECK W/PLUG | Warne Surgical Products, Ltd. | 1984-04-18 | 13 | 0 |
| K841412 | ROLLED NECK W/TAP | Warne Surgical Products, Ltd. | 1984-04-18 | 13 | 0 |
| K830399 | COUPLING/VALVE | Khi, Inc. | 1983-03-10 | 31 | 0 |
| K830056 | ARTEC TWIST VALVE | Artec Environmental Monitoring Division | 1983-03-09 | 62 | 0 |
| K822216 | VOLUMETRIC CONTROLLER | Quest Medical, Inc. | 1982-08-16 | 21 | 0 |
| K822116 | ANESTHESIA BREATHING BAG, VARIOUS SIZES | Life Design Systems, Inc. | 1982-08-16 | 28 | 0 |
| K821309 | ESPREE', BREATHING BAG | Esp Plastics, Inc. | 1982-05-21 | 17 | 0 |
| K800155 | DISPOSAL LITER BREATHING BAG | Dryden Corp. | 1980-02-21 | 29 | 0 |
| K791910 | THREE LITER BAG #M-512 | Mem Medical, Inc. | 1979-10-09 | 14 | 0 |
| K791463 | PARA-VENT | Cameron Medical Corp. | 1979-09-17 | 42 | 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