Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CCW — Predicate Candidate Screening
64 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
290 days90th percentile
64clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191602 | APA Oxy Blade | Venner Medical (Singapore) Pte, Ltd. | 2019-08-02 | 46 | 0 |
| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DB | Girgis Scope, LLC | 2017-06-22 | 199 | 0 |
| K140951 | YEESCOPE LARYNGOSCOPES | Yeescope Pty. , Ltd. | 2014-11-10 | 210 | 0 |
| K121378 | AIRTRAQ SP AIRTRAQ AVANT | Prodol Meditec , Ltd. | 2012-06-21 | 44 | 0 |
| K063477 | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET | Novamed, LLC | 2007-02-09 | 85 | 0 |
| K062523 | TRU-MR LARYNGOSCOPE SET | Truphatek International, Ltd. | 2006-11-17 | 81 | 1 |
| K062230 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL | Minrad, Inc. | 2006-08-31 | 29 | 0 |
| K062231 | MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MOD | Minrad, Inc. | 2006-08-31 | 29 | 0 |
| K041852 | MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 31000 | Minrad, Inc. | 2004-11-15 | 130 | 0 |
| K984101 | FLEXIBLADE | Arco Medic , Ltd. | 1999-09-03 | 290 | 0 |
| K971377 | GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE | Wilson Greatbatch Technologies, Inc. | 1998-04-30 | 381 | 0 |
| K970619 | GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOP | Wilson Greatbatch Technologies, Inc. | 1997-11-19 | 274 | 0 |
| K945590 | SCOPETEX(TM) | Smith Helms Mulliss & Moore, L.L.P. | 1997-05-20 | 918 | 0 |
| K961832 | BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER | Blue Ridge Medical, Inc. | 1996-09-06 | 116 | 0 |
| K945301 | LARYNGOSCOPE COVER | Sotiria Mourkidou, M.D. | 1996-05-31 | 578 | 0 |
| K954787 | ILLUMINATOR | Hospitak, Inc. | 1996-01-31 | 105 | 0 |
| K954438 | SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE | Rms Div. | 1995-12-29 | 95 | 0 |
| K954446 | AUGUSTINE INTUBATION GUIDE | Augustine Medical, Inc. | 1995-12-29 | 95 | 0 |
| K953179 | CLM LARYNGOSCOPE | Penlon , Ltd. | 1995-10-06 | 88 | 0 |
| K951147 | LEIGH MED. TECH. LARYNGOSCOPE BLADE COVER | Leigh Med Tech, Inc. | 1995-06-08 | 87 | 0 |
| K951804 | KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC L | KARL STORZ Endoscopy-America, Inc. | 1995-06-05 | 47 | 0 |
| K945425 | MCINTOSH, MILLER, FOREGGER BABY | Rudolf Riester GmbH & Co. KG | 1995-03-20 | 136 | 0 |
| K945901 | DIRECT VIEW 2001 FIBERLIGHT | Mercury Medical | 1994-12-27 | 25 | 0 |
| K944428 | LITE-BLADE | Eare Consulting Service | 1994-11-15 | 64 | 0 |
| K945269 | OPTUS LARYNGOSCOPES | Optus, Inc. | 1994-11-07 | 10 | 0 |
| K944686 | FIBEROPTIC LARYNGOSCOPE HANDLE | Fiberoptic Medical Products, Inc. | 1994-11-04 | 42 | 0 |
| K941319 | THE WUSCOPE SYSTEM | Achi Corp. | 1994-10-04 | 200 | 0 |
| K930804 | FILLISCOPE | Filliscope, Inc. | 1993-10-07 | 233 | 0 |
| K921263 | SUNLITE LARYNGOSCOPE | Sunmed, Inc. | 1993-06-01 | 442 | 0 |
| K926158 | SLATER SLEEVE | Tadco, Inc. | 1993-03-19 | 101 | 0 |
| K922019 | LARYNGOSCOPE RIGID | Eastmed Enterprises, Inc. | 1993-01-26 | 271 | 0 |
| K922275 | UPSHERSCOPE(TM) | Upsher Laryngoscope Co. | 1993-01-06 | 237 | 0 |
| K915161 | AUGUSTINE FIBEROPTIC LARYNGOSCOPE | Augustine Medical, Inc. | 1992-05-29 | 197 | 0 |
| K921166 | AUGUSTINE GUIDE KIT | Augustine Medical, Inc. | 1992-04-23 | 43 | 0 |
| K905273 | BAUMAN DISPOSABLE LARYNGOSCOPE BLADES | Vital Signs, Inc. | 1992-03-24 | 487 | 0 |
| K915804 | PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. | Propper Mfg. Co., Inc. | 1992-03-20 | 87 | 0 |
| K914741 | AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED | Eastmed Enterprises, Inc. | 1992-02-03 | 108 | 0 |
| K914168 | AUGUSTINE GUIDE KIT WITH GAUZE SPONGE | Augustine Medical, Inc. | 1991-10-07 | 20 | 0 |
| K912905 | LARYNGOSCOPE | Acorn Group, Inc. | 1991-09-30 | 90 | 0 |
| K904918 | BELSCOPE LARYNGOSCOPE | Avulunga Pty. , Ltd. | 1991-07-22 | 264 | 0 |
| K901164 | NEUSTEIN LARYNGOSCOPE | Neutech Corp. | 1990-10-09 | 211 | 0 |
| K901680 | BAUMAN RIGID LARYNGOSCOPE | Palex Intl. SA | 1990-07-12 | 91 | 0 |
| K901489 | MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) | Eastmed Enterprises, Inc. | 1990-04-10 | 12 | 0 |
| K895954 | LARYNGOSTAT LARYNGOSCOPE HANDLE | Michigan Instruments, Inc. | 1989-10-30 | 19 | 0 |
| K883830 | FIBER OPTIC LARYNGOSCOPE | Effner, Inc. | 1988-10-25 | 46 | 0 |
| K883819 | BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P | Circon Acmi | 1988-10-17 | 39 | 0 |
| K884073 | LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) | Eastmed Enterprises, Inc. | 1988-10-13 | 16 | 0 |
| K883296 | LARYNGOSCOPE | Lothar Scharras | 1988-10-13 | 70 | 0 |
| K882433 | LARYNGOSCOPE RIGID | Eastmed Enterprises, Inc. | 1988-09-02 | 80 | 0 |
| K883414 | LARYNGOSCOPE BLADES | Truphatek, Ltd. | 1988-08-19 | 4 | 1 |
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