Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Extracorporeal Medical Specialities, Inc. · Predicate Candidate Screening
69 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
155 days90th percentile
69clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843955 | EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR | Extracorporeal Medical Specialities, Inc. | 1984-11-29 | 51 | 0 |
| K840262 | HANCOCK PERICARDIAL PATCH | Extracorporeal Medical Specialities, Inc. | 1984-05-30 | 132 | 0 |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | Extracorporeal Medical Specialities, Inc. | 1984-05-30 | 119 | 0 |
| K840057 | EXP* 500 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1984-02-04 | 26 | 0 |
| K840146 | EXP* 700 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1984-02-04 | 22 | 0 |
| K831423 | THERAPEUTIC EXCHANGE SYSTEM | Extracorporeal Medical Specialities, Inc. | 1984-01-03 | 245 | 0 |
| K832547 | ULTRAFILTRATION CONTROLLER | Extracorporeal Medical Specialities, Inc. | 1984-01-03 | 155 | 0 |
| K833476 | INTERSEPT 40 MICRON FILTER W/TUBING | Extracorporeal Medical Specialities, Inc. | 1983-12-27 | 81 | 0 |
| K833477 | INTERSEPT 40 MICRON FILTER | Extracorporeal Medical Specialities, Inc. | 1983-12-27 | 81 | 0 |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | Extracorporeal Medical Specialities, Inc. | 1983-10-14 | 164 | 0 |
| K832053 | SINGLE PATIENT SYS. II MODEL DM-450 | Extracorporeal Medical Specialities, Inc. | 1983-09-29 | 94 | 0 |
| K830863 | HANCOCK PERICARDIAL PATCH | Extracorporeal Medical Specialities, Inc. | 1983-08-31 | 166 | 0 |
| K831029 | HEMOPERFUSION SYSTEM TP-400 | Extracorporeal Medical Specialities, Inc. | 1983-08-26 | 149 | 0 |
| K830908 | BICARBONATE/VARIABLE SODIUM KIT-DM-367 | Extracorporeal Medical Specialities, Inc. | 1983-06-08 | 79 | 0 |
| K831433 | EXTRASENSR ULTRAFILTRATION MONITOR | Extracorporeal Medical Specialities, Inc. | 1983-06-02 | 29 | 0 |
| K822337 | KF-101-07 DIALYZER | Extracorporeal Medical Specialities, Inc. | 1983-02-16 | 196 | 0 |
| K822338 | KF-101-10 DIALYZER | Extracorporeal Medical Specialities, Inc. | 1983-02-16 | 196 | 0 |
| K822339 | KF-101-13 DIALYZER | Extracorporeal Medical Specialities, Inc. | 1983-02-16 | 196 | 0 |
| K823752 | EXTRACORPOREAL SUBCLAVIAN CATHETER KIT | Extracorporeal Medical Specialities, Inc. | 1983-01-14 | 31 | 0 |
| K823108 | INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT | Extracorporeal Medical Specialities, Inc. | 1982-11-30 | 40 | 0 |
| K823205 | EXV VENOUS RESERVOIR BAG & HOLDER | Extracorporeal Medical Specialities, Inc. | 1982-11-24 | 28 | 0 |
| K822340 | EXTRACORPOREAL SINGLE NEEDLE MODULE | Extracorporeal Medical Specialities, Inc. | 1982-11-03 | 91 | 0 |
| K822385 | EXTRAPURE REVERSE OSMOSIS WATER UNIT | Extracorporeal Medical Specialities, Inc. | 1982-10-13 | 65 | 0 |
| K822738 | TRIEX-IH DIALYZER | Extracorporeal Medical Specialities, Inc. | 1982-09-24 | 15 | 0 |
| K822283 | TS-000 ARTERIOVENOUS BLOOD TUBING SET | Extracorporeal Medical Specialities, Inc. | 1982-08-27 | 28 | 0 |
| K820600 | HANCOCK VASCULAR GRAFT | Extracorporeal Medical Specialities, Inc. | 1982-07-08 | 126 | 0 |
| K821216 | INTERPULSE MEMBRANE OXYGENATOR | Extracorporeal Medical Specialities, Inc. | 1982-06-02 | 36 | 0 |
| K821138 | TS-180 SERIES TUBING SET | Extracorporeal Medical Specialities, Inc. | 1982-05-10 | 19 | 0 |
| K821139 | SPS-SINGLE PATIENT SYSTEM | Extracorporeal Medical Specialities, Inc. | 1982-05-10 | 19 | 0 |
| K820169 | MALE LUER CONNECTOR & HINGED CAP | Extracorporeal Medical Specialities, Inc. | 1982-02-05 | 15 | 0 |
| K813205 | INTERSEPT CARDIOTOMY RESERVOIR/FILTER | Extracorporeal Medical Specialities, Inc. | 1982-01-28 | 76 | 0 |
| K811972 | EXTRASENSR ULTRAFILTRATION MONITOR | Extracorporeal Medical Specialities, Inc. | 1981-11-16 | 129 | 0 |
| K811444 | MODEL DM-333 DIALYSIS CONTROL STATION | Extracorporeal Medical Specialities, Inc. | 1981-06-23 | 32 | 0 |
| K811439 | EXP 200 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1981-06-12 | 21 | 0 |
| K811440 | EXP 600 PARALLEL PLATE DIALYZER | Extracorporeal Medical Specialities, Inc. | 1981-06-12 | 21 | 0 |
| K811292 | PARALLEL PLATE DIALYZER HOLDER | Extracorporeal Medical Specialities, Inc. | 1981-06-02 | 22 | 0 |
| K802364 | EXTRACORPOREAL'S EXP 400 PARALLEL PLATE | Extracorporeal Medical Specialities, Inc. | 1981-01-29 | 122 | 0 |
| K803003 | INTERPULSE MEMBRANE OXYGENATION SYSTEM | Extracorporeal Medical Specialities, Inc. | 1981-01-22 | 57 | 0 |
| K803059 | INTERSEPT* VENOUS RESERVOIR BAG & HOLDER | Extracorporeal Medical Specialities, Inc. | 1980-12-22 | 19 | 0 |
| K802880 | EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS | Extracorporeal Medical Specialities, Inc. | 1980-12-17 | 30 | 0 |
| K802874 | ARTERIOVENOUS BLOOD TUBING SETS | Extracorporeal Medical Specialities, Inc. | 1980-11-25 | 8 | 0 |
| K801344 | EXTRACORPOREALS' ALTERNATE MEMBRANE | Extracorporeal Medical Specialities, Inc. | 1980-07-21 | 46 | 0 |
| K800771 | MOD. DM-356 IPS INTERFACE MODULE | Extracorporeal Medical Specialities, Inc. | 1980-05-20 | 43 | 0 |
| K800772 | MOD. DM-357 BICARBONATE RETROFIT KIT | Extracorporeal Medical Specialities, Inc. | 1980-05-14 | 37 | 0 |
| K800549 | MODEL TRIEX-L HOLLOW FIBER DIALYZER | Extracorporeal Medical Specialities, Inc. | 1980-04-10 | 31 | 0 |
| K800270 | TRIEX-2 HOLLOW FIBER DIALYZER | Extracorporeal Medical Specialities, Inc. | 1980-02-26 | 20 | 0 |
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. | Extracorporeal Medical Specialities, Inc. | 1980-02-21 | 24 | 10 |
| K792173 | MODELS DM-360 & DM-350-L SINGLE PATIENT | Extracorporeal Medical Specialities, Inc. | 1979-11-16 | 18 | 0 |
| K792174 | MODEL DM 353 & DM-353-L SINGLE NEEDLE | Extracorporeal Medical Specialities, Inc. | 1979-11-16 | 18 | 0 |
| K791961 | EXTRACORPOREAL'S MODEL EX-85 DIALYZER | Extracorporeal Medical Specialities, Inc. | 1979-11-13 | 43 | 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