Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ipco Corp. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
87 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871270 | PERFORM DENTURE BASE RESIN | Ipco Corp. | 1987-05-29 | 59 | 0 |
| K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | Ipco Corp. | 1985-05-29 | 98 | 0 |
| K850906 | TACTILE PLUS DENTAL ELEVATORS | Ipco Corp. | 1985-04-12 | 38 | 0 |
| K842837 | SAFE & SOFT MAXI SHILEDS | Ipco Corp. | 1984-10-15 | 87 | 0 |
| K842836 | SAFE & SOFT MINI PADS & MAXI PADS | Ipco Corp. | 1984-10-15 | 87 | 0 |
| K842838 | SAFE & SOFT PANTY SHIELDS | Ipco Corp. | 1984-10-05 | 77 | 0 |
| K841953 | ULTRA SHIELD BRIEFS | Ipco Corp. | 1984-07-19 | 66 | 0 |
| K840755 | MINIGARD DISPOSABLE LINERS | Ipco Corp. | 1984-04-13 | 50 | 0 |
| K840754 | MAXISHIELD INCONTINENCE CARE SYSTEM | Ipco Corp. | 1984-04-13 | 50 | 0 |
| K840753 | AMBEZE DISPOSABLE INCONTINENCE PANTS | Ipco Corp. | 1984-04-13 | 50 | 0 |
| K800291 | ENDEX REAMERS PULP CANAL, ENDODONTIC | Ipco Corp. | 1980-02-19 | 8 | 0 |
| K800293 | FILE, PULP CANAL | Ipco Corp. | 1980-02-19 | 8 | 0 |
| K800292 | ENDEX BROACH, ENDODONTIC | Ipco Corp. | 1980-02-19 | 8 | 0 |
| K792373 | IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA- | Ipco Corp. | 1980-02-13 | 79 | 0 |
| K800117 | TRU-PULSE PADS | Ipco Corp. | 1980-02-11 | 24 | 0 |
| K782164 | STIMULATOR, MODEL 1-600 ELECTRIC NERVR | Ipco Corp. | 1979-03-08 | 76 | 0 |
| K781678 | DEFIBRILLATOR, MARK II | Ipco Corp. | 1978-12-12 | 71 | 0 |
| K781679 | MONITOR/MINI SCOPE | Ipco Corp. | 1978-12-12 | 71 | 0 |
| K781420 | SPECIALTY SPONGES | Ipco Corp. | 1978-10-03 | 49 | 0 |
| K780416 | PANTRIDGE MK III DEFIBRILLATOR/MONITOR | Ipco Corp. | 1978-04-21 | 38 | 0 |
| K761221 | NON-STERILE PREGELLED GROUNDING PAD | Ipco Corp. | 1977-01-12 | 36 | 0 |
| K760203 | TUBE, STERILE NON-CONDUCTIVE CONNECTING | Ipco Corp. | 1976-07-19 | 11 | 0 |
| K760202 | TUBE, STERILE CONDUCTIVE CONNECTING | Ipco Corp. | 1976-07-19 | 11 | 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