Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HNR — Predicate Candidate Screening
44 FDA 510(k) clearances under this product code; the 50 most recent screened below.
29 daysmedian FDA review time
94 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022835 | STEPHENS DISPOSABLE FORCEPS | Stephens Instruments | 2002-11-01 | 66 | 0 |
| K895434 | ALCON FOLDING FORCEPS | Alcon Laboratories | 1989-12-04 | 87 | 0 |
| K891487 | SOFT LENS FOLDING BLOCK | Western Medical Products, Inc. | 1989-08-15 | 151 | 0 |
| K893199 | PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR | Allergan Medical Optics | 1989-06-16 | 51 | 0 |
| K885230 | MCDONALD FOLDING FORCEPS | Alcon Laboratories | 1989-05-17 | 148 | 0 |
| K881049 | BRADBURY INTRAOCULAR RETINAL KIT CAT #200 | Microline Pentax, Inc. | 1988-09-12 | 185 | 0 |
| K883197 | IOL IMPLANTATION FORCEPS | D & D Surgical | 1988-08-22 | 25 | 0 |
| K880274 | ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS | Advanced Surgical Products, Inc. | 1988-02-05 | 15 | 0 |
| K864183 | OPHTHALMIC SURGICAL INSTRUMENTS | Techno Ophthalmics Intl. | 1986-11-28 | 32 | 0 |
| K864266 | OPHTHALMIC KNIFE & FORCEPS | Western Medical Products, Inc. | 1986-11-28 | 30 | 0 |
| K864071 | FAULKNER FORCEPS | Staar Surgical Co. | 1986-11-13 | 24 | 0 |
| K863992 | THORNTON TITANIUM FORCEPS (VARIOUS TYPES) | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K864003 | PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS | Allergan, Inc. | 1986-10-31 | 17 | 0 |
| K863991 | THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND | Keeler Instruments, Inc. | 1986-10-31 | 17 | 0 |
| K863727 | FIXATION INSTRUMENTS | Medical Technology Development Corp. | 1986-10-31 | 38 | 0 |
| K861057 | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS | Precision-Cosmet Co., Inc. | 1986-04-24 | 36 | 0 |
| K861141 | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS | CooperVision, Inc. | 1986-04-24 | 29 | 0 |
| K860915 | STORZ/MAZZACCO LENS FORCEP | Storz Instrument Co. | 1986-04-15 | 35 | 0 |
| K854869 | INTRAOCULAR FORCEPS & SCISSORS | Mira, Inc. | 1986-03-05 | 91 | 0 |
| K852057 | ASCON SURGICAL INSTRUMENTS | Ascon Medical Instruments, Ltd. | 1985-06-27 | 49 | 0 |
| K851791 | 37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS | Artiberia | 1985-05-30 | 35 | 0 |
| K851792 | 37-940 TO 37-944 VARIOUS NOYES OPHTHALMIC FORCEPS | Artiberia | 1985-05-30 | 35 | 0 |
| K850119 | PHARMASEAL EYE PREP TRAY | American Pharmaseal Div. Ahsc | 1985-05-09 | 115 | 0 |
| K844129 | SHURE GRIP TYING FORCEPS | Mentor O & O, Inc. | 1984-11-21 | 29 | 0 |
| K843992 | CILCOR OPHTHALMIC INSTRUMENTS | Cilco, Inc. | 1984-11-21 | 41 | 0 |
| K842697 | ROOTMAN ORBITAL SURGERY INSTRUMENT SET | Downs Surgical , Ltd. | 1984-08-07 | 27 | 0 |
| K834355 | MICRO FORCEPS | Jedmed Instrument Co. | 1984-03-16 | 94 | 0 |
| K823174 | MICROSURGICAL INSTRUMENTS | Concept, Inc. | 1982-11-16 | 21 | 0 |
| K811658 | ANIS LENS IMPLANT FORCEPS #2 | American V. Mueller | 1981-06-26 | 14 | 0 |
| K803194 | FISHER-PICKERING INTRAOCULAR EYE MAGNET | Storz Instrument Co. | 1981-02-04 | 50 | 0 |
| K801465 | GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE | Edward Weck, Inc. | 1980-07-28 | 34 | 0 |
| K801467 | DODICK LENS HOLDING FORCEPS | Edward Weck, Inc. | 1980-07-28 | 34 | 0 |
| K800368 | OPHTHALMIC FORCEPS | Edward Weck, Inc. | 1980-03-12 | 21 | 0 |
| K791986 | FIX. & LENS FOR. #'S 3510,3512,3248,3795 | Edward Weck, Inc. | 1979-10-04 | 9 | 0 |
| K771003 | LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS | Edward Weck, Inc. | 1977-06-17 | 15 | 0 |
| K770101 | SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK | Edward Weck, Inc. | 1977-01-25 | 8 | 0 |
| K770105 | SHEPARD II, LENS FORCEP W/ LOCK | Edward Weck, Inc. | 1977-01-25 | 8 | 0 |
| K770099 | SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK | Edward Weck, Inc. | 1977-01-24 | 7 | 0 |
| K770100 | BINKHORST LENS FORCEP W/ IRRIGATOR | Edward Weck, Inc. | 1977-01-24 | 7 | 0 |
| K770097 | HERSHMAN LENS FORCEPS WITH IRRIGATOR | Edward Weck, Inc. | 1977-01-24 | 7 | 0 |
| K770102 | HERSHMAN LENS FORCEPS W/OUT IRRIGATOR | Edward Weck, Inc. | 1977-01-24 | 7 | 0 |
| K770104 | BINKHORST LENS FORCEPS W/OUT IRRIGATOR | Edward Weck, Inc. | 1977-01-24 | 7 | 0 |
| K761251 | WECK TYING FORCEP, STRAIGHT TITANIUM | Edward Weck, Inc. | 1976-12-16 | 3 | 0 |
| K761252 | WECK TYING FORCEP, CURVED TITANIUM | Edward Weck, Inc. | 1976-12-16 | 3 | 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