Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Respiratory Support Products, Inc. · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
203 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983862 | CLOUD 1 HUMIDIFICATION SYSTEM | Respiratory Support Products, Inc. | 1999-05-24 | 203 | 0 |
| K921190 | ADAP-TEMP TEMPERATURE SENSOR ADAPTER | Respiratory Support Products, Inc. | 1993-03-09 | 365 | 0 |
| K920469 | MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE | Respiratory Support Products, Inc. | 1992-09-11 | 228 | 0 |
| K921510 | GAS SAMPLING KIT MODIFICATION | Respiratory Support Products, Inc. | 1992-06-11 | 90 | 0 |
| K913082 | BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D | Respiratory Support Products, Inc. | 1991-12-11 | 202 | 0 |
| K912280 | BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D | Respiratory Support Products, Inc. | 1991-10-17 | 147 | 0 |
| K913083 | BI-TEMP TEMPERATURE MONITOR TM-201D | Respiratory Support Products, Inc. | 1991-10-17 | 147 | 0 |
| K903816 | URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR | Respiratory Support Products, Inc. | 1990-10-31 | 72 | 0 |
| K874694 | ADAP-TEMP, MODEL: AT-100 | Respiratory Support Products, Inc. | 1988-03-01 | 109 | 0 |
| K873472 | MEMBRANE HUMIDIFIER | Respiratory Support Products, Inc. | 1988-01-19 | 144 | 0 |
| K873205 | TYMPANIC TEMPERATURE SENSOR | Respiratory Support Products, Inc. | 1988-01-14 | 153 | 0 |
| K873448 | FOLEY CATHETER TEMPERATURE SENSOR | Respiratory Support Products, Inc. | 1987-12-07 | 103 | 0 |
| K873206 | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | Respiratory Support Products, Inc. | 1987-09-30 | 47 | 0 |
| K864043 | ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T | Respiratory Support Products, Inc. | 1986-12-15 | 60 | 0 |
| K863646 | ESOPHAGEAL RECTAL TEMPERATURE PROBE | Respiratory Support Products, Inc. | 1986-11-25 | 68 | 0 |
| K864195 | SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T | Respiratory Support Products, Inc. | 1986-11-19 | 23 | 2 |
| K863987 | BI-TEMP TEMPERATURE MONITOR | Respiratory Support Products, Inc. | 1986-11-18 | 35 | 0 |
| K864044 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T | Respiratory Support Products, Inc. | 1986-11-04 | 19 | 0 |
| K863640 | MODIFIED GAS SAMPLING KIT | Respiratory Support Products, Inc. | 1986-10-08 | 35 | 0 |
| K861286 | GAS SAMPLING KIT | Respiratory Support Products, Inc. | 1986-04-11 | 4 | 0 |
| K854212 | ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR | Respiratory Support Products, Inc. | 1986-01-03 | 78 | 0 |
| K854632 | ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE | Respiratory Support Products, Inc. | 1986-01-03 | 43 | 0 |
| K854934 | VENTILATOR PRESSURE ALARM MODEL VPA-100 | Respiratory Support Products, Inc. | 1985-12-24 | 14 | 0 |
| K840420 | AIRWAY PRESSURE MONITOR | Respiratory Support Products, Inc. | 1984-04-05 | 65 | 0 |
| K834522 | VENTI-VOICE NASAL CATHETER | Respiratory Support Products, Inc. | 1984-01-17 | 27 | 0 |
| K802675 | ENDOTRACHEAL TUBE HOLDER | Respiratory Support Products, Inc. | 1980-11-19 | 21 | 0 |
| K790312 | ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR | Respiratory Support Products, Inc. | 1979-02-21 | 8 | 6 |
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