Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgikos, Inc. — Predicate Candidate Screening
56 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
84 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K875107 | HEALTH CARE EYE PROTECTION | Surgikos, Inc. | 1988-03-21 | 98 | 0 |
| K874653 | STERILE SURGICAL SCRUB BRUSH | Surgikos, Inc. | 1987-12-30 | 47 | 0 |
| K861441 | NEUTRALON SURGICAL GLOVES | Surgikos, Inc. | 1986-05-30 | 43 | 0 |
| K852870 | BARRIER SURGICAL GOWN | Surgikos, Inc. | 1985-07-23 | 15 | 0 |
| K822535 | CIDEX*DIALYZER DISINFECTING SOLUTION | Surgikos, Inc. | 1982-09-30 | 37 | 0 |
| K820543 | BARRIER ANTIMICROBIAL INCISE DRAPE | Surgikos, Inc. | 1982-07-22 | 142 | 0 |
| K820542 | SURGIKOS INCISE DRAPE | Surgikos, Inc. | 1982-06-02 | 92 | 0 |
| K811871 | BACTERICIDAL INCISE DRAPE | Surgikos, Inc. | 1981-08-20 | 50 | 0 |
| K810316 | SURGIKOS FACE MASK | Surgikos, Inc. | 1981-02-23 | 17 | 0 |
| K801864 | BARRIER APERTURED DRAPE | Surgikos, Inc. | 1980-08-20 | 15 | 0 |
| K801863 | BARRIER TOWEL DRAPE | Surgikos, Inc. | 1980-08-20 | 15 | 0 |
| K800152 | SURGIKOS NEUTRALON BR. SURGEON'S GLOVE | Surgikos, Inc. | 1980-02-19 | 28 | 0 |
| K791719 | BARRIER & FACE MASK WITH INNER FACING | Surgikos, Inc. | 1979-10-04 | 35 | 0 |
| K791440 | BARRIER* X-RAY CASSETTE DRAPE | Surgikos, Inc. | 1979-08-28 | 28 | 0 |
| K791486 | FABRIC 450* TOWEL DRAPE | Surgikos, Inc. | 1979-08-28 | 22 | 0 |
| K791438 | BARRIER* C-ARM DRAPE | Surgikos, Inc. | 1979-08-28 | 28 | 0 |
| K791439 | BARRIER* OVERHEAD TABLE DRAPE | Surgikos, Inc. | 1979-08-28 | 28 | 0 |
| K791500 | BARRIER *450* TAPE STRIP | Surgikos, Inc. | 1979-08-28 | 26 | 0 |
| K791032 | CARDIAC CATHETERIZATION SHEETS/PACKS | Surgikos, Inc. | 1979-06-15 | 11 | 0 |
| K790804 | PURGE LINE UNIT | Surgikos, Inc. | 1979-05-25 | 31 | 0 |
| K790725 | BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* | Surgikos, Inc. | 1979-05-11 | 28 | 0 |
| K790431 | TREATED BARRIER INCISE DRAPE | Surgikos, Inc. | 1979-05-04 | 63 | 0 |
| K790435 | INTERSEPT* BLOOD FILTER W/ TUBING BYPASS | Surgikos, Inc. | 1979-03-27 | 42 | 0 |
| K790306 | EDGE PROTECTOR, BARRIER | Surgikos, Inc. | 1979-02-22 | 9 | 0 |
| K790225 | LIMB SHEET WITH FABRIC 450 | Surgikos, Inc. | 1979-02-21 | 19 | 0 |
| K790224 | PADIATRY PACK & SHEET WITH FABRIC 450 | Surgikos, Inc. | 1979-02-16 | 14 | 0 |
| K781861 | FILTER, EXTRACORPOREAL BLOOD HOLDER | Surgikos, Inc. | 1978-11-15 | 9 | 0 |
| K781707 | FILTER, ARTERIAL BLOOD W/TUBING BYPASS | Surgikos, Inc. | 1978-10-26 | 16 | 0 |
| K780840 | BARRIER LAPAROTOMY SHEET 450 | Surgikos, Inc. | 1978-08-14 | 83 | 0 |
| K780844 | BARRIER OBSTETRICAL PACK FABRIC 450 | Surgikos, Inc. | 1978-08-14 | 84 | 0 |
| K780856 | BARRIER GYNECOLOGY PACK FABRIC 450 | Surgikos, Inc. | 1978-08-14 | 82 | 0 |
| K780842 | BARRIER BASIC PACK FABRIC 450 | Surgikos, Inc. | 1978-08-14 | 84 | 0 |
| K780843 | BARRIER ABDOMINAL PACK FABRIC 450 | Surgikos, Inc. | 1978-08-14 | 84 | 0 |
| K780839 | BARRIER PEDIATRIC/INCISE DRAPE 450 | Surgikos, Inc. | 1978-08-14 | 83 | 0 |
| K780841 | BARRIER MEDIUM SHEET 450 | Surgikos, Inc. | 1978-08-14 | 83 | 0 |
| K780282 | BARRIER HIP PACK W/ FABRIC 450 | Surgikos, Inc. | 1978-02-28 | 7 | 1 |
| K772182 | SURGICAL GOWN, REINFORCED | Surgikos, Inc. | 1977-12-08 | 13 | 0 |
| K770560 | BARRIER O.B. PACK IV | Surgikos, Inc. | 1977-04-05 | 13 | 0 |
| K770250 | GOWN, SURGICAL, SURGINE | Surgikos, Inc. | 1977-03-07 | 27 | 0 |
| K761204 | BARRIER IMPERVIOUS BACK TABLE COVER | Surgikos, Inc. | 1977-01-12 | 36 | 0 |
| K760896 | BARRIER ORTHOPAEDIC SPLIT SHEET | Surgikos, Inc. | 1977-01-05 | 71 | 0 |
| K760937 | BARRIER NEURO SHEET | Surgikos, Inc. | 1976-12-21 | 50 | 0 |
| K760991 | SURGINE FACE MASK | Surgikos, Inc. | 1976-11-16 | 11 | 0 |
| K760554 | APPAREL, BARRIER SCRUB | Surgikos, Inc. | 1976-11-12 | 73 | 0 |
| K760890 | BARRIER IMPERVIOUS S-OCKINETTE | Surgikos, Inc. | 1976-11-11 | 16 | 0 |
| K760902 | BARRIER UNDER BUTTOCKS DRAPE | Surgikos, Inc. | 1976-11-11 | 16 | 0 |
| K760933 | BARRIER UNIVERSAL SHEET | Surgikos, Inc. | 1976-11-11 | 13 | 0 |
| K760903 | BARRIER FABRIC 450 SURGICAL GOWNS | Surgikos, Inc. | 1976-11-11 | 16 | 0 |
| K760865 | BARRIER FASHION BONNET | Surgikos, Inc. | 1976-11-03 | 16 | 0 |
| K760807 | BARRIER GENERAL SURGERY PACK | Surgikos, Inc. | 1976-11-03 | 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