Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CBS — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
244 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974903 | GAS MODULE II, MODEL 0998-00-0143 | Datascope Corp. | 1998-03-13 | 72 | 0 |
| K953795 | VITALMAX 4100 | Pace Tech, Inc. | 1996-07-01 | 322 | 0 |
| K960490 | AS/3 COMPACT AIRWAY MODULE M-CAIOV | Datex Medical Instrumentation, Inc. | 1996-05-03 | 91 | 0 |
| K951366 | RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) | Riken Keiki Co., Ltd. | 1995-08-02 | 128 | 0 |
| K950101 | RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS | Marquette Electronics, Inc. | 1995-03-21 | 69 | 0 |
| K943458 | AS/3 AIRWAY MODULE | Datex Division Instrumentarium Corp. | 1995-02-14 | 211 | 0 |
| K942737 | POET IQ WITH FIVE AGENT CAPABILITY | Criticare Systems, Inc. | 1995-02-09 | 244 | 0 |
| K932389 | 8100 ANESTHETIC AGENT MONITOR | Biochem International, Inc. | 1993-12-03 | 200 | 0 |
| K905754 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | 1991-06-17 | 175 | 0 |
| K896629 | NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR | Nellcor, Inc. | 1990-02-12 | 82 | 0 |
| K896216 | HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A | Hewlett-Packard Co. | 1990-01-16 | 78 | 0 |
| K890446 | ANESTHETIC GAS MONITOR | Bruel & Kjaer Instruments, Inc. | 1989-08-11 | 196 | 0 |
| K873194 | SPECTRAMED RESPIRATORY GAS ANALYZER | Draeger Medical, Inc. | 1987-10-30 | 78 | 0 |
| K863801 | TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR | Traverse Medical Monitors | 1987-01-12 | 105 | 0 |
| K832113 | NORMAC ANESTHETIC AGENT MONITOR | Datex Division Instrumentarium Corp. | 1983-09-12 | 74 | 0 |
| K810585 | SARA | Allied Healthcare Products, Inc. | 1981-03-24 | 20 | 0 |
| K802614 | ENGSTROM EMMA ANESTHETIC GAS MONITOR | Lkb Instruments, Inc. | 1981-01-07 | 78 | 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