Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgicot, Inc. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
252 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962605 | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | Surgicot, Inc. | 1997-03-11 | 252 | 0 |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | Surgicot, Inc. | 1994-04-13 | 401 | 0 |
| K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. | Surgicot, Inc. | 1986-12-17 | 125 | 0 |
| K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR | Surgicot, Inc. | 1986-07-17 | 206 | 0 |
| K854631 | ASSERT EO BIOLOGICAL TEST PACK | Surgicot, Inc. | 1986-05-27 | 190 | 1 |
| K854902 | SURGICOT STEAM TEST PACK | Surgicot, Inc. | 1986-05-20 | 162 | 2 |
| K840541 | NEURO SPONGE | Surgicot, Inc. | 1984-04-23 | 75 | 0 |
| K840471 | EYE SPEAR | Surgicot, Inc. | 1984-03-16 | 42 | 0 |
| K840470 | SURGISCRIBE MARKING PEN | Surgicot, Inc. | 1984-03-12 | 38 | 0 |
| K830739 | PRO-GUARD | Surgicot, Inc. | 1983-03-29 | 21 | 0 |
| K820302 | SURGIPEEL SELF-SEAL PACKAGING SYSTEM | Surgicot, Inc. | 1982-02-24 | 20 | 0 |
| K800029 | SURGICOT 2 INDICATOR SYSTEM | Surgicot, Inc. | 1980-03-12 | 65 | 0 |
| K771846 | SUOGIPEEL PACKAGING SYSTEM | Surgicot, Inc. | 1977-10-13 | 15 | 0 |
| K771032 | POUCHES, PEEL OPEN, BREATHABLE | Surgicot, Inc. | 1977-07-14 | 35 | 0 |
| K770593 | CORRUGATED TUBING #770 & 771 | Surgicot, Inc. | 1977-04-19 | 22 | 0 |
| K770585 | AEROSOL T ADAPTER, #752 | Surgicot, Inc. | 1977-04-05 | 8 | 0 |
| K770587 | VENTILATOR ADAPTOR, #751 | Surgicot, Inc. | 1977-04-05 | 8 | 0 |
| K770586 | UNIVERSAL MOUTHPIECE, #750 | Surgicot, Inc. | 1977-04-05 | 8 | 0 |
| K761254 | BAND-AGE ICE-BANDAGE | Surgicot, Inc. | 1977-02-24 | 73 | 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