Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Consolidated Medical Equipment, Inc. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
99 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854040 | I.V. DRESSING | Consolidated Medical Equipment, Inc. | 1986-01-09 | 99 | 0 |
| K850130 | PRN ECG ELECTRODE | Consolidated Medical Equipment, Inc. | 1985-04-09 | 85 | 0 |
| K850132 | DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC | Consolidated Medical Equipment, Inc. | 1985-04-09 | 85 | 0 |
| K850037 | CLOSED WOUND DRAIN | Consolidated Medical Equipment, Inc. | 1985-03-19 | 71 | 0 |
| K844942 | PLURA-GARD CHEST DRAINAGE SYSTEM | Consolidated Medical Equipment, Inc. | 1985-03-12 | 82 | 0 |
| K850131 | CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS | Consolidated Medical Equipment, Inc. | 1985-03-05 | 50 | 0 |
| K850311 | DISPOS. CONDUCTIVE ADHESIVE TENS PAD | Consolidated Medical Equipment, Inc. | 1985-03-05 | 39 | 0 |
| K850129 | MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN | Consolidated Medical Equipment, Inc. | 1985-02-28 | 45 | 0 |
| K850133 | VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. | Consolidated Medical Equipment, Inc. | 1985-02-28 | 45 | 0 |
| K844372 | HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE | Consolidated Medical Equipment, Inc. | 1985-02-21 | 100 | 0 |
| K844371 | HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE | Consolidated Medical Equipment, Inc. | 1985-02-20 | 99 | 0 |
| K820443 | SURGI-SCRAPE | Consolidated Medical Equipment, Inc. | 1982-03-08 | 18 | 0 |
| K820082 | POST-OP ELECTRODE (TENS ELECTRODE) | Consolidated Medical Equipment, Inc. | 1982-01-28 | 16 | 0 |
| K802282 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Consolidated Medical Equipment, Inc. | 1980-10-10 | 21 | 0 |
| K800024 | I.V. TAPE DOWN HOLDER | Consolidated Medical Equipment, Inc. | 1980-01-29 | 22 | 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