Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spenco Medical Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
213 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981902 | SPENCO SILICONE GEL SHEET | Spenco Medical Corp. | 1998-06-25 | 24 | 0 |
| K922228 | 2ND SKIN STERILE ADHESIVE STRIP | Spenco Medical Corp. | 1992-12-11 | 213 | 0 |
| K911550 | 2ND SKIN MOIST BURN PADS WITH ALOE | Spenco Medical Corp. | 1991-09-06 | 151 | 0 |
| K910927 | SPENCIO SKIN GUARD KIT | Spenco Medical Corp. | 1991-06-03 | 90 | 0 |
| K896533 | SPENCO BREAST FORMS | Spenco Medical Corp. | 1989-12-13 | 29 | 0 |
| K894898 | 2ND SKIN NON-STICK MOIST BURN PADS | Spenco Medical Corp. | 1989-08-23 | 22 | 0 |
| K820906 | SPENCO CRYOPRESS | Spenco Medical Corp. | 1982-05-13 | 42 | 0 |
| K811184 | SPENCO DERMAL PADS | Spenco Medical Corp. | 1981-05-20 | 21 | 0 |
| K791726 | HYDROGEL-PREP | Spenco Medical Corp. | 1979-11-20 | 77 | 0 |
| K791162 | GELSKIN | Spenco Medical Corp. | 1979-09-04 | 71 | 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