Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biochem International, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
366 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920083 | BIOCHEM MODEL 3302 NEWOX2 OXIMETER | Biochem International, Inc. | 1994-04-11 | 825 | 0 |
| K932389 | 8100 ANESTHETIC AGENT MONITOR | Biochem International, Inc. | 1993-12-03 | 200 | 0 |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | Biochem International, Inc. | 1993-05-26 | 429 | 0 |
| K920082 | BIOCHEM MODEL 3301 NEWOX1 OXIMETER | Biochem International, Inc. | 1993-01-07 | 366 | 0 |
| K910381 | BIOCHEM TEMPERATURE/ FIO2 MODULE | Biochem International, Inc. | 1991-08-22 | 205 | 0 |
| K911351 | BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP | Biochem International, Inc. | 1991-08-22 | 148 | 0 |
| K903222 | BIOCHEM 6100 NON-INVASIVE MONITOR | Biochem International, Inc. | 1990-09-04 | 43 | 0 |
| K901861 | BIOCHEM 9100 MULTIGAS MONITOR | Biochem International, Inc. | 1990-07-27 | 93 | 0 |
| K893877 | BIOCHEM 3100 OXIMETER | Biochem International, Inc. | 1989-12-20 | 208 | 0 |
| K892646 | BIOCHEM 8100 ANESTHETIC AGENT MONITOR | Biochem International, Inc. | 1989-08-31 | 141 | 0 |
| K890874 | BIOCHEM 520 BREATH INDICATOR | Biochem International, Inc. | 1989-06-15 | 114 | 0 |
| K873856 | BIOCHEM 9090 CAPNOGRAPH/SAO2 | Biochem International, Inc. | 1987-12-17 | 86 | 0 |
| K873959 | BIOCHEM 8800 CAPNOMETER | Biochem International, Inc. | 1987-12-11 | 74 | 0 |
| K871133 | BIOCHEM 8090 CAPNOGRAPH | Biochem International, Inc. | 1987-04-21 | 32 | 1 |
| K870163 | BIOCHEM MICROSPAN 1040 OXIMETER | Biochem International, Inc. | 1987-03-03 | 48 | 0 |
| K863186 | BIOCHEM CO/OX 1000 | Biochem International, Inc. | 1986-11-07 | 80 | 0 |
| K854333 | BIOCHEM 515 RESPIRATION MONITOR | Biochem International, Inc. | 1986-05-30 | 214 | 0 |
| K842303 | MICROSPAN -PH MONITOR | Biochem International, Inc. | 1984-10-12 | 123 | 0 |
| K840918 | MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT | Biochem International, Inc. | 1984-04-17 | 47 | 0 |
| K812643 | LIFESPAN CO2 | Biochem International, Inc. | 1981-11-16 | 61 | 0 |
| K811470 | LIFESPAN 100 | Biochem International, Inc. | 1981-06-12 | 17 | 0 |
| K803260 | SENSOMAT MUSCLE/TISSUE PH | Biochem International, Inc. | 1981-02-02 | 40 | 0 |
| K803014 | SENSOMAT | Biochem International, Inc. | 1980-12-22 | 24 | 0 |
| K801657 | NON-INVASIVE, BLOOD PRESSURE MONITOR | Biochem International, Inc. | 1980-08-20 | 30 | 0 |
| K800073 | TRANSCUTANEOUS OXYGEN MONITOR | Biochem International, Inc. | 1980-02-05 | 22 | 0 |
| K790597 | SENSOMAT SIDEARM ADAPTER | Biochem International, Inc. | 1979-07-10 | 106 | 0 |
| K781910 | MONITOR, SENSOMATIII OXYGEN | Biochem International, Inc. | 1978-12-26 | 42 | 0 |
| K771722 | SENSOMAT | Biochem International, Inc. | 1977-09-26 | 13 | 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