Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
BSR · Predicate Candidate Screening
32 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
205 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162729 | Aintree Intubation Catheter, Arndt Airway Exchange Catheter | Cook Incorporated | 2017-08-11 | 316 | 0 |
| K962361 | TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND | Laerdal Medical Corp. | 1996-09-05 | 78 | 0 |
| K954771 | TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION | Laerdal Medical Corp. | 1996-05-09 | 205 | 0 |
| K943104 | MOLLOY INTUBATING STYLETTE | Molloy Corp. | 1996-04-18 | 659 | 0 |
| K955238 | RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE | Rusch Intl. | 1996-02-06 | 84 | 0 |
| K953677 | LIGHTED FLEXGUIDE (MODIFICATION) | Scientific Sales Intl., Inc. | 1995-08-25 | 18 | 0 |
| K952100 | RUSCH ENDOTRACHEAL TUBE STYLET | Rusch, Inc. | 1995-08-08 | 96 | 0 |
| K952266 | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE | Stebar Instrument Corp. | 1995-06-12 | 28 | 0 |
| K950713 | AIRGUIDE STYLETTE | Polamedco, Inc. | 1995-05-17 | 91 | 0 |
| K950380 | FLEXTITIP STYLETTE | Polamedco, Inc. | 1995-02-10 | 10 | 0 |
| K944729 | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED | Coast Medical, Inc. | 1994-12-21 | 86 | 5 |
| K940799 | FLEXGUIDE | Scientific Sales Intl., Inc. | 1994-08-18 | 177 | 0 |
| K933598 | ENDOSTAR(TM) STYLET | Fiberoptic Medical Products, Inc. | 1994-01-25 | 183 | 0 |
| K935797 | SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE | Stebar Instrument Corp. | 1994-01-12 | 41 | 0 |
| K932081 | LIGHTED INTUBATION SYLET | Aaron Medical, Inc. | 1993-07-27 | 89 | 0 |
| K904999 | WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE | Opticon Medical, Inc. | 1993-01-26 | 812 | 0 |
| K922842 | STYLET AND TRACHEAL LIGHTWAND (STL) | Laerdal California, Inc. | 1992-12-18 | 189 | 0 |
| K921128 | ENDOTRACHEAL TUBE STYLET | Eastmed Enterprises, Inc. | 1992-06-02 | 84 | 0 |
| K914965 | DISPOSABLE STYLETTE WITH END CAP | Pivic Promedco | 1992-05-27 | 204 | 0 |
| K920468 | AUGUSTINE STYLET | Augustine Medical, Inc. | 1992-04-23 | 87 | 0 |
| K912690 | AUGUSTINE GUIDE(TM) KIT | Augustine Medical, Inc. | 1991-09-04 | 78 | 0 |
| K910659 | AUGUSTINE STYLET | Augustine Medical, Inc. | 1991-05-17 | 92 | 0 |
| K905133 | STYLET TRACHAEL TUBE | Medical Devices, Inc. | 1991-04-22 | 158 | 0 |
| K905052 | BIVONA ENDOTRACHEAL TUBE STYLET | Bivona Medical Technologies | 1991-04-02 | 145 | 0 |
| K902180 | TRACHEAL TUBE STYLET | Sims Surgical, Inc. | 1990-07-19 | 65 | 3 |
| K865108 | N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE | Ackrad Laboratories | 1987-02-10 | 41 | 0 |
| K844557 | ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE | Ackrad Laboratories | 1984-12-17 | 26 | 0 |
| K843490 | TUBE-STAT | Concept, Inc. | 1984-10-04 | 28 | 0 |
| K832773 | SHERI-I-SLIP INTUBATING STYLET | Sheridan Catheter Corp. | 1983-09-12 | 27 | 0 |
| K802416 | SALEM/RESCE INTUBATION GUIDE | Scientific Sales Intl., Inc. | 1980-10-23 | 17 | 0 |
| K772046 | INTUBATION PROCEDURE KIT | American Hospital Supply Corp. | 1977-11-23 | 26 | 0 |
| K770374 | STYLETTE, SLICK, CAT. NO. 2000B | Medical Products Div. P.O.L.A. Plasti | 1977-03-30 | 33 | 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