Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FYF — Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
120 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972227 | SHOE COVER | American Seal Co. | 1997-09-09 | 88 | 0 |
| K955833 | NIOMED SURGICAL CAPS | Amerasia Corp. | 1996-03-15 | 80 | 0 |
| K954556 | SURGICAL CAP | Thai Disposable Products Co., Ltd. | 1996-03-12 | 162 | 0 |
| K954454 | NIOMED SURGICAL HOOD | Amerasia Corp. | 1996-01-23 | 120 | 0 |
| K954455 | NIOMED BOUFFANT CAPS | Amerasia Corp. | 1996-01-23 | 120 | 0 |
| K953879 | SURGEON'S CAP | American Threshold Industries, Inc. | 1996-01-05 | 142 | 0 |
| K953878 | BOUFFANT CAP | American Threshold Industries, Inc. | 1996-01-05 | 142 | 0 |
| K913700 | DISPOSABLE BOUFFANT CAP | Gem Nonwovews, Inc. | 1991-10-04 | 46 | 0 |
| K882346 | INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD | Nordbye, Milchman, Barlage | 1988-06-30 | 23 | 0 |
| K882284 | SURGEONS CAP | A Plus International, Inc. | 1988-06-23 | 23 | 0 |
| K882283 | BOUFFANT CAP | A Plus International, Inc. | 1988-06-23 | 23 | 0 |
| K880481 | CARETEX SURGEON'S CAPS | James River Corp. | 1988-02-24 | 19 | 0 |
| K875261 | KIMBERLY-CLARK FULL COVERAGE HOOD | Kimberly-Clark Corp. | 1988-01-22 | 32 | 0 |
| K874066 | SURGICAL CAPS | Interpro Intl., Inc. | 1987-11-04 | 30 | 0 |
| K873830 | TECNOL SURGEON'S CAP | Tecnol New Jersey Wound Care, Inc. | 1987-10-23 | 32 | 0 |
| K870617 | VARIOUS TYES OF SURGICAL GARMENTS | Greene International Corp. | 1987-03-09 | 25 | 0 |
| K870618 | VARIOUS TYPES OF SURGICAL GARMENTS | Kin Yuh Hung Co., Ltd. | 1987-03-09 | 25 | 0 |
| K863359 | BOUFFANT-STYLE SURGICAL CAP | Kimberly-Clark Corp. | 1986-09-29 | 27 | 0 |
| K851558 | SURGICAL CAP CALOT | Roseburg SA | 1985-04-30 | 14 | 0 |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | Medicon, Inc. | 1985-01-10 | 38 | 0 |
| K831357 | BOUNDARY HEADWEAR | Procter & Gamble Mfg. Co. | 1983-06-02 | 37 | 0 |
| K810199 | DISPOSABLE SURGERY CAPS & HOODS | Anago, Inc. | 1981-02-13 | 21 | 0 |
| K802186 | DISPOSABLE NURSES CAP | Anago, Inc. | 1980-09-26 | 16 | 0 |
| K800810 | FLARE DIS. NONWOVEN HEAD COVERS | Flare Products, Inc. | 1980-05-20 | 40 | 0 |
| K800511 | SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP | American Convertors Div., American Pharmaseal | 1980-04-16 | 42 | 0 |
| K770260 | CAP, CLARION NURSES OR (TECHNIC) | Sherwood Medical Industries | 1977-03-07 | 23 | 0 |
| K770259 | CAP, CLARION SURGEON'S | Sherwood Medical Industries | 1977-03-07 | 24 | 0 |
| K770258 | CAP, CLARION NURSES, STYLE BOUFFANT 21 | Sherwood Medical Industries | 1977-03-07 | 24 | 0 |
| K761069 | P.S.M. BOTIQUE CAP | The Owenby Co. | 1976-12-30 | 44 | 0 |
| K761068 | P.S.M. BOUFFANT CAP | The Owenby Co. | 1976-12-30 | 44 | 0 |
| K761071 | P.S.M. JUSTA KAP | The Owenby Co. | 1976-12-30 | 44 | 0 |
| K760861 | SURGICAL CORP. | Surgikos, Inc. | 1976-11-03 | 16 | 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