Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Downs Surgical , Ltd. — Predicate Candidate Screening
60 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
256 days90th percentile
60clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | Downs Surgical , Ltd. | 1990-10-31 | 76 | 0 |
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | Downs Surgical , Ltd. | 1990-10-31 | 76 | 0 |
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | Downs Surgical , Ltd. | 1990-10-31 | 76 | 0 |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | Downs Surgical , Ltd. | 1990-10-31 | 76 | 0 |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K900610 | SHEPPERD CANNULA STILLETTE & OBDURATOR SET | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K900609 | SHEPPERD STRAIGHT AND CURVED NEEDLES | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K900616 | SHEPPERD CUTTING FORCEPS | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K900608 | SHEPPERD LUMBAR DISCECTOMY SYSTEM | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K900613 | SHEPPERD SHELTER TUBE COMPLETE & DRILL | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K900615 | SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE | Downs Surgical , Ltd. | 1990-10-22 | 256 | 0 |
| K881757 | RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS | Downs Surgical , Ltd. | 1988-07-15 | 81 | 0 |
| K881912 | SANO CLIP APPLIERS & REMOVERS | Downs Surgical , Ltd. | 1988-06-06 | 28 | 0 |
| K881911 | NEW SIZES SUGITA CLIPS | Downs Surgical , Ltd. | 1988-06-06 | 28 | 0 |
| K880278 | MALLEABLE PTFE COATED BRAIN SPATULAE | Downs Surgical , Ltd. | 1988-02-11 | 20 | 0 |
| K874630 | RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS | Downs Surgical , Ltd. | 1987-12-23 | 43 | 0 |
| K873934 | RANGE OF CROCODILE ACTION INSTRUMENTS | Downs Surgical , Ltd. | 1987-12-17 | 83 | 0 |
| K873933 | RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM | Downs Surgical , Ltd. | 1987-12-17 | 83 | 0 |
| K871947 | MODIFIED HUCKSTEP INTRAMEDULLARY NAIL | Downs Surgical , Ltd. | 1987-08-05 | 78 | 0 |
| K871956 | MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT | Downs Surgical , Ltd. | 1987-06-23 | 34 | 0 |
| K870887 | WARD'S BREAST MEASURING DEVICE | Downs Surgical , Ltd. | 1987-03-31 | 26 | 0 |
| K864515 | RING UPM TOTAL HIP REPLACEMENT | Downs Surgical , Ltd. | 1987-03-13 | 116 | 0 |
| K864631 | MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE. | Downs Surgical , Ltd. | 1986-12-18 | 23 | 0 |
| K863119 | CANNULATED LAG SCREWS | Downs Surgical , Ltd. | 1986-09-03 | 20 | 0 |
| K862945 | DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES | Downs Surgical , Ltd. | 1986-08-20 | 15 | 0 |
| K861629 | KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES | Downs Surgical , Ltd. | 1986-08-12 | 105 | 0 |
| K862696 | TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP | Downs Surgical , Ltd. | 1986-07-30 | 15 | 0 |
| K862331 | FUJITSU MALLEABLE - TIP BRAIN SPATULA | Downs Surgical , Ltd. | 1986-07-01 | 12 | 0 |
| K861630 | NEUROSURGICAL INSTURMENTS (VARIOUS) | Downs Surgical , Ltd. | 1986-05-09 | 10 | 0 |
| K854711 | FIBRELIGHT ILLUMINATING ORAL RETRACTORS | Downs Surgical , Ltd. | 1986-02-25 | 95 | 0 |
| K853708 | LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE | Downs Surgical , Ltd. | 1986-02-14 | 163 | 0 |
| K853589 | SHAH SELF-CLEARING MASTOID SUCTION TUBE | Downs Surgical , Ltd. | 1985-12-23 | 118 | 0 |
| K853588 | FIBRELIGHT NASAL SPECULA | Downs Surgical , Ltd. | 1985-12-18 | 113 | 0 |
| K853709 | A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM | Downs Surgical , Ltd. | 1985-11-15 | 72 | 0 |
| K853640 | WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL | Downs Surgical , Ltd. | 1985-10-29 | 70 | 0 |
| K840547 | WILCOX ROD & PLATE BENDER | Downs Surgical , Ltd. | 1984-10-31 | 266 | 0 |
| K843371 | VALVOTOMY KNIFE | Downs Surgical , Ltd. | 1984-10-25 | 58 | 0 |
| K843388 | WELLINGTON HOSPITAL PATTERN SELF-RETAIN | Downs Surgical , Ltd. | 1984-10-01 | 33 | 0 |
| K843100 | INSTRUMENTS FOR MICRO ANASTOMOSIS | Downs Surgical , Ltd. | 1984-09-27 | 51 | 0 |
| K842698 | BRITISH SPINAL FUSION SET | Downs Surgical , Ltd. | 1984-09-12 | 63 | 0 |
| K842700 | BASILDON-GARDNER SPINAL FRAME | Downs Surgical , Ltd. | 1984-09-12 | 63 | 0 |
| K842697 | ROOTMAN ORBITAL SURGERY INSTRUMENT SET | Downs Surgical , Ltd. | 1984-08-07 | 27 | 0 |
| K842701 | HOPPENSTEIN MICROSURGICAL SPINAL INSTRU | Downs Surgical , Ltd. | 1984-08-02 | 22 | 0 |
| K842699 | ISLAM BONE MARROW ASPIRATION NEEDLES | Downs Surgical , Ltd. | 1984-08-02 | 22 | 0 |
| K842702 | ROSENBERG SKIN GRAFTING KNIVES | Downs Surgical , Ltd. | 1984-08-02 | 22 | 0 |
| K841125 | HUCKSTEPS STAPLES | Downs Surgical , Ltd. | 1984-05-23 | 69 | 0 |
| K821772 | SURGITA/MIZHO MICRONEUROSURGERY HEAD FR | Downs Surgical , Ltd. | 1982-09-28 | 104 | 0 |
| K821358 | MODIFIED RONGEURS FOR SPINAL & ORTH. S. | Downs Surgical , Ltd. | 1982-05-28 | 22 | 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