Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
New England Surgical Instrument Corp. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
33 daysmedian FDA review time
81 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K895331 | ELECTROSURGICAL ELECTRODE | New England Surgical Instrument Corp. | 1989-09-15 | 16 | 0 |
| K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | New England Surgical Instrument Corp. | 1989-09-15 | 16 | 0 |
| K883963 | RANEY AND LEROY-RANEY SCALP CLIP | New England Surgical Instrument Corp. | 1988-10-07 | 17 | 0 |
| K883396 | HANDSWITCHING MONOPOLAR PENCIL | New England Surgical Instrument Corp. | 1988-09-13 | 33 | 0 |
| K880863 | BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 | New England Surgical Instrument Corp. | 1988-04-19 | 49 | 1 |
| K880859 | SURGICAL BURS | New England Surgical Instrument Corp. | 1988-03-21 | 20 | 0 |
| K872271 | VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS | New England Surgical Instrument Corp. | 1987-06-26 | 14 | 0 |
| K872209 | ARTHROPLASTY MALLET | New England Surgical Instrument Corp. | 1987-06-23 | 14 | 0 |
| K864770 | SUCTION TUBE | New England Surgical Instrument Corp. | 1987-02-24 | 81 | 0 |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | New England Surgical Instrument Corp. | 1987-02-12 | 69 | 0 |
| K864771 | CHUCK HANDLE | New England Surgical Instrument Corp. | 1987-02-04 | 61 | 0 |
| K864402 | BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE | New England Surgical Instrument Corp. | 1987-01-20 | 75 | 7 |
| K861876 | CRANIO BLADES AND WIRE PASS DRILL | New England Surgical Instrument Corp. | 1986-05-30 | 15 | 0 |
| K831426 | ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS | New England Surgical Instrument Corp. | 1983-06-08 | 36 | 0 |
| K831236 | BIPOLAR CARD | New England Surgical Instrument Corp. | 1983-06-02 | 48 | 0 |
| K820344 | ROWE SHOULDER INSTR. FOR BANKHART REPAIR | New England Surgical Instrument Corp. | 1982-03-08 | 28 | 0 |
| K811821 | CAROTID ARTERY CLAMP & TOOLS | New England Surgical Instrument Corp. | 1981-09-24 | 87 | 0 |
| K811820 | BIPOLAR COAGULATING FORCEPS | New England Surgical Instrument Corp. | 1981-07-28 | 29 | 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