KDC
67 FDA 510(k) clearances · Product code
57 daysmedian time to decision
147 days90th percentile
67clearances measured
FDA profile
- Official device name
- Instrument, Surgical, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2016: 11 · 2018: 71 · 2019: 16 · 2020: 13 · 2023: 15 · 2026: 24
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE SURGICAL SCISSORS AND FORCEPS (K943229) | Y.M.K. International Co., Ltd. | 1994-08-19 |
| SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (K936226) | Meadox Medicals, Div. Boston Scientific Corp. | 1994-03-07 |
| THERMUFF BAG (K920153) | Techstyles | 1992-07-01 |
| MANUAL SURGICAL INSTRUMENTS (K920263) | Phoenix Instruments Div. | 1992-05-06 |
| DISPOSABLE CAUTERY ABRASIVE PAD (K915064) | American Medical Mfg., Inc. | 1992-03-11 |
| INSTRUMENT ORGANIZER (K914960) | O.R. Concepts, Inc. | 1992-02-28 |
| SHUR-GRIP (K912834) | Inman Medical Corp. | 1991-07-26 |
| DISPOSABLE INTRODUCER SHEATH (K910079) | Applied Vascular Devices, Inc. | 1991-02-27 |
| VESSELOOPS (K905240) | Sparta Surgical Corp. | 1991-02-06 |
| BRADLEY TENACULUM HOLDER (K903649) | Marlo Surgical Technology | 1990-11-02 |
| RICHARD-ALLAN VESSEL LOOPS (K900566) | Richard-Allan Medical Ind., Inc. | 1990-05-03 |
| KEY VASCULAR LOOPS (K896676) | Key Surgical, Inc. | 1990-02-27 |
| SPOON (K854894) | Euro-Med Intl. | 1986-05-02 |
| ATLANTIC GRASPER (K854898) | Euro-Med Intl. | 1986-05-02 |
| MAX-I-GRASP (K854897) | Euro-Med Intl. | 1986-05-02 |
| BASKET FORCEP (K854895) | Euro-Med Intl. | 1986-05-02 |
| PACIFIC GRASPER (K854901) | Euro-Med Intl. | 1986-05-02 |
| HOOK PROBE (K854890) | Euro-Med Intl. | 1986-05-02 |
| HOOK SCISSOR (K854896) | Euro-Med Intl. | 1986-05-02 |
| INSTRUMENT MAKAR DISPOSALBE LOOP (K853597) | Instrument Makar, Inc. | 1985-09-23 |
| SUTURE-AID BOOTIES (K832441) | Omega-Med Intl., Inc. | 1984-03-05 |
| SDC VASCULAR TIES (K833355) | Science Development Corp. | 1984-01-27 |
| PMT-OPTICA LINE (K831118) | Pmt, Inc. | 1984-01-25 |
| MICRO-EDGE DISPOSABLE BLADES (K832680) | Micromedics, Inc. | 1983-10-14 |
| C-LOOPS (K830800) | Concept, Inc. | 1983-10-04 |
| DRAVON T CLAMP (K831842) | Dravon Medical, Inc. | 1983-09-26 |
| DISPOSABLE FLOOR INSTRUMENTS (K831911) | Ormed Mfg., Inc. | 1983-09-12 |
| SAFETY PINS & RUBBER BANDS (K831915) | Ormed Mfg., Inc. | 1983-09-12 |
| DISPOSABLE NEEDLE HOLDER (K831665) | Medcare Products | 1983-09-12 |
| PLASTIC THUMB FORCEPS (K831664) | Medcare Products | 1983-09-12 |
| DISPOSABLE SCISSORS (K831661) | Medcare Products | 1983-08-25 |
| DISPOSABLE SCALPELS (K831798) | I M, Inc. | 1983-07-19 |
| DISPOSABLE HEMOSTAT (STRAIGHT&CURVED (K831662) | Medcare Products | 1983-07-19 |
| DEVO'N LOOPS (K830248) | Devon Industries, Inc. | 1983-03-08 |
| NEGATIVE PRESSURE ARTERIAL BLOOD LINE (K830326) | Erika, Inc. | 1983-02-28 |
| KAM SUCKER (K822065) | The Anspach Effort, Inc. | 1982-08-16 |
| KOLOR KODE TM (K821166) | Devon Industries, Inc. | 1982-05-13 |
| PEDIATRIC SUCKER (K820638) | 3M Health Care, Sarns | 1982-04-09 |
| AXIOM LIG-A-BOOTS (K820161) | Axiom Medical, Inc. | 1982-03-15 |
| OLSEN #770 DISPOSABLE HOLSTER (K820158) | Olsen Electro-Surgical Instruments, Inc. | 1982-02-05 |
| TIP WIPE (K811712) | Devon Industries, Inc. | 1981-07-20 |
| TIP-VU (K811822) | Instranetics, Inc. | 1981-07-20 |
| SHARPS CADDY FB (K811823) | Instranetics, Inc. | 1981-07-20 |
| CAUTERY CADDY PAD (K811824) | Instranetics, Inc. | 1981-07-20 |
| ALTRACLUDE (K811303) | R&H Medical, Inc. | 1981-06-16 |
| FLEX-TEMPLATE (K811280) | Mick Radio-Nuclear Instruments, Inc. | 1981-06-02 |
| DAVIS & GECK NEEDLE/SHARPS COUNTER (K811191) | Davis & Geck, Inc. | 1981-05-27 |
| SURGICAL STAPLE REMOVER (K811120) | Acme United Corp. | 1981-05-05 |
| OMED SILICONE INSTRUMENT COVERS (K810883) | Omega-Med Intl., Inc. | 1981-04-23 |
| SKIN STAPLE REMOVER (K810785) | Rowley Mfg. Co. | 1981-04-10 |
| VASCULAR TIE (VAS-TIE) (K810080) | Sil-Med Corp. | 1981-04-02 |
| OMED SILICONE LOOPS (K810260) | Omega-Med Intl., Inc. | 1981-02-26 |
| OMED FABRIC INSTRUMENT COVERS (K810269) | Omega-Med Intl., Inc. | 1981-02-26 |
| SEARLE VASCULAR LOOPS (K802485) | G.D. Searle and Co. | 1981-02-12 |
| SWR DISPOSABLE PREP RAZOR (K810112) | G.D. Searle and Co. | 1981-02-04 |
| SURGITEK MEDI-LOOPS (K803156) | Medical Engineering Corp. | 1981-01-15 |
| COBE CENTRY 2 VARIABLE CONCENTRATE-18- (K802895) | Cobe Laboratories, Inc. | 1980-12-22 |
| SAFE T COUNT (K802865) | Instranetics, Inc. | 1980-12-18 |
| SHARPS CADDY MAGNETIC & SHARPS CADDY FOA (K802866) | Instranetics, Inc. | 1980-11-17 |
| SI-14 (K801908) | Kmi Medical, Inc. | 1980-11-12 |
| AXIOM VESSEL LOOPS (K800015) | Axiom Medical, Inc. | 1980-03-25 |
| SPONGE COUNTER BAGS (K791434) | Medicare Industries, Inc. | 1979-10-09 |
| Y-TYPE BLOOD SET (K780880) | Abbott Laboratories | 1978-06-30 |
| INSTRUMENT CLEANING BRUSH (K780399) | Ransom and Randolph | 1978-03-17 |
| VESSEL-STABILIZER (K771702) | Med General | 1977-12-13 |
| SUTURE REMOVAL SET, STERILE (K770794) | Lukens Corp. | 1977-05-06 |
| LANCET, BLOOD, STERILE STAINLESS STEEL (K760362) | Aeroceuticals | 1976-09-13 |
Track KDC automatically
Every clearance here is in the API, with alerts when new ones post.