Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicomp, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
196 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173170 | Epicardia Anywhere | Medicomp, Inc. | 2018-01-10 | 103 | 0 |
| K161916 | TelePatch Cardiac Monitor | Medicomp, Inc. | 2016-12-21 | 162 | 0 |
| K091696 | SAVI WIRELESS, MODEL PM500 | Medicomp, Inc. | 2009-10-26 | 138 | 0 |
| K090834 | EPICARDIA 5000 | Medicomp, Inc. | 2009-05-15 | 49 | 0 |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Medicomp, Inc. | 2005-03-24 | 99 | 0 |
| K981119 | CARDIOPAL MODEL NUMBER PM20 | Medicomp, Inc. | 1998-10-14 | 201 | 0 |
| K952846 | EPICARDIA | Medicomp, Inc. | 1995-09-18 | 89 | 0 |
| K943915 | HEAT AND MOISTURE EXCHANGER FILTER (HME) | Medicomp, Inc. | 1994-10-14 | 64 | 0 |
| K900207 | EPICARDIA 4000 | Medicomp, Inc. | 1990-07-31 | 196 | 0 |
| K883103 | EPICARDIA PC/FC | Medicomp, Inc. | 1988-09-22 | 62 | 0 |
| K881770 | EPICARDIA LE/FD | Medicomp, Inc. | 1988-05-31 | 35 | 0 |
| K880434 | MEDICOMP STRAIGHT SWIVEL ADAPTOR | Medicomp, Inc. | 1988-03-31 | 59 | 0 |
| K872837 | EPICARIDA, LE | Medicomp, Inc. | 1987-11-04 | 107 | 0 |
| K864896 | MEDICOMP INHALANT MASK ELBOW | Medicomp, Inc. | 1987-02-20 | 67 | 0 |
| K863643 | EPICARDIA, PC/FD | Medicomp, Inc. | 1986-12-05 | 78 | 0 |
| K861280 | MEDICOMP CPAP NASAL CANNULA | Medicomp, Inc. | 1986-05-09 | 32 | 0 |
| K852632 | GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB | Medicomp, Inc. | 1986-01-03 | 197 | 0 |
| K852866 | HYDRO-BAC FILTER | Medicomp, Inc. | 1986-01-01 | 177 | 0 |
| K851666 | MEDI-COMP NEONATAL OXYGEN HOOD | Medicomp, Inc. | 1985-08-06 | 105 | 0 |
| K851070 | RESP-BAC BACTERIA FILTER | Medicomp, Inc. | 1985-06-14 | 88 | 0 |
| K843513 | EPICARDIA, PC | Medicomp, Inc. | 1984-10-22 | 46 | 0 |
| K834034 | MODEM ACCESSORY FOR EPI CARDIA SYS | Medicomp, Inc. | 1984-05-09 | 168 | 0 |
| K830013 | EPI CARDIA SYS. - AMBULATORY MONITOR | Medicomp, Inc. | 1983-02-28 | 56 | 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