Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Keeler Instruments, Inc. — Predicate Candidate Screening
60 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
149 days90th percentile
60clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | 2019-02-08 | 283 | 0 |
| K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PR | Keeler Instruments, Inc. | 2011-12-08 | 139 | 0 |
| K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417 | Keeler Instruments, Inc. | 2010-12-10 | 415 | 0 |
| K100500 | PSL CLASSIC SLIT LAMP | Keeler Instruments, Inc. | 2010-03-09 | 15 | 0 |
| K062412 | CRYOMATIC | Keeler Instruments, Inc. | 2006-11-06 | 81 | 0 |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 2006-05-23 | 57 | 0 |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Keeler Instruments, Inc. | 2003-11-26 | 142 | 0 |
| K992954 | KEELER CRYO MASTER & PROBES | Keeler Instruments, Inc. | 1999-12-21 | 111 | 0 |
| K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | Keeler Instruments, Inc. | 1999-03-25 | 57 | 0 |
| K973064 | KEELER TEARSCOPE-PLUS | Keeler Instruments, Inc. | 1998-04-07 | 232 | 0 |
| K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 1997-04-02 | 89 | 0 |
| K942180 | KEELER MULTILASE 3000 | Keeler Instruments, Inc. | 1994-11-22 | 202 | 0 |
| K942104 | KEELER VANTAGE INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 1994-08-04 | 94 | 0 |
| K914956 | KEELER KONAN SPECULAR MICROSCOPE SP5500 | Keeler Instruments, Inc. | 1992-02-03 | 90 | 0 |
| K911721 | KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION | Keeler Instruments, Inc. | 1991-06-25 | 69 | 0 |
| K900111 | KEELER KONAN SPECULAR MICROSCOPE SP3300 | Keeler Instruments, Inc. | 1990-03-23 | 73 | 0 |
| K895213 | MICROLASE BY LASER TRABECULOPLASTY | Keeler Instruments, Inc. | 1989-10-31 | 74 | 0 |
| K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | Keeler Instruments, Inc. | 1989-09-21 | 149 | 0 |
| K893173 | VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC) | Keeler Instruments, Inc. | 1989-06-05 | 41 | 0 |
| K891610 | HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER | Keeler Instruments, Inc. | 1989-06-05 | 77 | 0 |
| K893170 | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | Keeler Instruments, Inc. | 1989-06-05 | 41 | 0 |
| K893172 | VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) | Keeler Instruments, Inc. | 1989-06-05 | 41 | 0 |
| K890086 | MICROLASE 8 0 0 (OPHTHALMIC LASER) | Keeler Instruments, Inc. | 1989-03-15 | 64 | 0 |
| K882772 | LQ1106 OPHTHALMIC YAG LASER | Keeler Instruments, Inc. | 1988-08-26 | 51 | 0 |
| K874555 | KEELER ACU 22XT OPHTHALMIC CRYO UNIT | Keeler Instruments, Inc. | 1988-01-29 | 86 | 0 |
| K874411 | DONALDSON NATURAL EYEPATCH 'PATIENT PAK' | Keeler Instruments, Inc. | 1988-01-27 | 91 | 0 |
| K873388 | KEELER CTU CRYO SYSTEM | Keeler Instruments, Inc. | 1987-11-13 | 81 | 0 |
| K871369 | VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: | Keeler Instruments, Inc. | 1987-09-24 | 170 | 0 |
| K870750 | KEELER PULSAIR NON CONTACT TONOMETER | Keeler Instruments, Inc. | 1987-03-17 | 20 | 0 |
| K870203 | KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 | Keeler Instruments, Inc. | 1987-02-12 | 23 | 0 |
| K864290 | RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE | Keeler Instruments, Inc. | 1986-12-15 | 45 | 0 |
| K864467 | HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN | Keeler Instruments, Inc. | 1986-12-15 | 33 | 0 |
| K863992 | THORNTON TITANIUM FORCEPS (VARIOUS TYPES) | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K863990 | THORNTON TITANIUM SILVER SPATULA | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K863989 | THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K863991 | THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K863988 | THORTON TITANIUM HOOK ANGLED RIGHT | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K861747 | KEELER FIBEROPTIC HEADLAMP | Keeler Instruments, Inc. | 1986-08-21 | 107 | 0 |
| K861746 | KEELER DUAL LIGHTSOURCE | Keeler Instruments, Inc. | 1986-08-21 | 107 | 0 |
| K861744 | SAPPHIRE KNIFE BLADE | Keeler Instruments, Inc. | 1986-06-09 | 34 | 0 |
| K861748 | RUBY & SAPPHIRE BLADE HOLDER | Keeler Instruments, Inc. | 1986-06-02 | 27 | 0 |
| K861749 | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | Keeler Instruments, Inc. | 1986-05-23 | 17 | 0 |
| K861745 | VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET | Keeler Instruments, Inc. | 1986-05-13 | 7 | 0 |
| K860979 | DONALDSON NATURAL EYEPATCH | Keeler Instruments, Inc. | 1986-04-04 | 21 | 0 |
| K854422 | SERIES 25 SLIMLINE CRYO PROBES | Keeler Instruments, Inc. | 1985-12-30 | 56 | 0 |
| K854411 | KEELER-COMPACT CRYO SYSTEM | Keeler Instruments, Inc. | 1985-12-30 | 59 | 0 |
| K854440 | MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 | Keeler Instruments, Inc. | 1985-12-16 | 41 | 0 |
| K854256 | KEELER AMOILS SURGICAL ASTIGOMETER | Keeler Instruments, Inc. | 1985-12-13 | 52 | 0 |
| K854244 | THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 1985-11-12 | 22 | 1 |
| K853161 | THE VICKERS STANDARD MICROSURGERY SET | Keeler Instruments, Inc. | 1985-11-07 | 100 | 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